Trial Outcomes & Findings for Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients (NCT NCT01061736)
NCT ID: NCT01061736
Last Updated: 2017-06-28
Results Overview
ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1675 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2017-06-28
Participant Flow
The study was conducted at 247 centers in 36 countries. Overall, 3715 participants were screened between March 2010 and July 2012, 2040 of whom were screen failures. Screen failures were mainly due to failure to meet the inclusion criterion for severity of the disease and/or due to meeting the exclusion criterion.
Randomization was performed centrally with allocation generated by Interactive Voice/Web Response System, stratified by geographical region and prior biological use. 306 participants were randomized in Part A. 1369 participants were randomized in part B, 172 before dose selection (cohort 1) and 1197 after dose selection (cohort 2).
Participant milestones
| Measure |
Part A: SAR 100 mg qw
Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of methotrexate (MTX) for 12 weeks.
|
Part A: SAR 150 mg qw
Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 100 mg q2w
Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 150 mg q2w
Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 200 mg q2w
Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: Placebo qw
Placebo (for sarilumab) qw on top of MTX for 12 weeks.
|
Part B Cohort 1: Non-selected Doses
Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections as in Part A on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
|
Part B: SAR 150 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)
Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
|
Part B: SAR 200 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)
Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
|
Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)
Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
51
|
51
|
52
|
52
|
84
|
430
|
427
|
428
|
|
Overall Study
Treated
|
50
|
50
|
51
|
51
|
51
|
52
|
84
|
428
|
426
|
428
|
|
Overall Study
Rescued
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
61
|
55
|
168
|
|
Overall Study
COMPLETED
|
37
|
46
|
45
|
48
|
45
|
49
|
0
|
336
|
330
|
354
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
6
|
3
|
7
|
3
|
84
|
94
|
97
|
74
|
Reasons for withdrawal
| Measure |
Part A: SAR 100 mg qw
Sarilumab 100 mg subcutaneous (SC) injection weekly (qw) on top of methotrexate (MTX) for 12 weeks.
|
Part A: SAR 150 mg qw
Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 100 mg q2w
Sarilumab 100 mg SC injection every other week (q2w) alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 150 mg q2w
Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 200 mg q2w
Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: Placebo qw
Placebo (for sarilumab) qw on top of MTX for 12 weeks.
|
Part B Cohort 1: Non-selected Doses
Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections as in Part A on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
|
Part B: SAR 150 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)
Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
|
Part B: SAR 200 mg q2w (Cohort 1 [Selected Dose]+Cohort 2)
Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
|
Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)
Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Dose regimen not selected
|
0
|
0
|
0
|
0
|
0
|
0
|
79
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
13
|
1
|
3
|
2
|
4
|
1
|
4
|
63
|
67
|
34
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
1
|
1
|
1
|
2
|
1
|
9
|
9
|
10
|
|
Overall Study
Poor compliance to protocol
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
5
|
9
|
|
Overall Study
Not treated
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Other than specified above
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
18
|
15
|
21
|
Baseline Characteristics
Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
Baseline characteristics by cohort
| Measure |
Part A: SAR 100 mg qw
n=50 Participants
Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 150 mg qw
n=50 Participants
Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 100 mg q2w
n=51 Participants
Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 150 mg q2w
n=51 Participants
Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 200 mg q2w
n=52 Participants
Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: Placebo qw
n=52 Participants
Placebo (for sarilumab) qw on top of MTX for 12 weeks.
|
Part B Cohort 1: Non-selected Doses
n=84 Participants
Sarilumab 100 mg qw, 150 mg qw or 100 mg q2w SC injections on top of MTX up to dose selection. After dose selection, participants were not continued but were allowed to participate in the open-label, long-term, extension study SARIL-RA-EXTEND (LTS11210).
|
Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)
n=430 Participants
Sarilumab 150 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
|
Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)
n=427 Participants
Sarilumab 200 mg SC injection q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
|
Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)
n=428 Participants
Placebo (for sarilumab) q2w on top of MTX for a maximum of 52 weeks. Participants with inadequate response from Week 16 could be rescued with high dose of sarilumab (SAR 200 mg q2w).
|
Total
n=1675 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
48.7 years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
55.2 years
STANDARD_DEVIATION 12.5 • n=10 Participants
|
51.1 years
STANDARD_DEVIATION 11.5 • n=115 Participants
|
50.3 years
STANDARD_DEVIATION 11.9 • n=6 Participants
|
50.8 years
STANDARD_DEVIATION 12.0 • n=6 Participants
|
51.1 years
STANDARD_DEVIATION 11.2 • n=64 Participants
|
51.04 years
STANDARD_DEVIATION 11.79 • n=17 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
69 Participants
n=115 Participants
|
345 Participants
n=6 Participants
|
359 Participants
n=6 Participants
|
346 Participants
n=64 Participants
|
1362 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
85 Participants
n=6 Participants
|
68 Participants
n=6 Participants
|
82 Participants
n=64 Participants
|
313 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Part A Intent-to-treat (ITT) population defined as all randomized participants.
ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF).
Outcome measures
| Measure |
Part A: SAR 100 mg qw
n=50 Participants
Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 150 mg qw
n=50 Participants
Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 100 mg q2w
n=51 Participants
Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 150 mg q2w
n=51 Participants
Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 200 mg q2w
n=52 Participants
Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: Placebo qw
n=52 Participants
Placebo (for sarilumab) qw on top of MTX for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
|
62 Percentage of participants
|
72 Percentage of participants
|
49 Percentage of participants
|
66.7 Percentage of participants
|
65.4 Percentage of participants
|
46.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: ITT population which included all participants randomized after dose selection (cohort 2).
ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.
Outcome measures
| Measure |
Part A: SAR 100 mg qw
n=400 Participants
Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 150 mg qw
n=399 Participants
Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 100 mg q2w
n=398 Participants
Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 150 mg q2w
Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 200 mg q2w
Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: Placebo qw
Placebo (for sarilumab) qw on top of MTX for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part B: Percentage of Participants Achieving ACR20 Response at Week 24
|
58 Percentage of participants
|
66.4 Percentage of participants
|
33.4 Percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Cohort 2 ITT population only and included participants with available data of HAQ-DI at baseline and on or before Week 16.
HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing.
Outcome measures
| Measure |
Part A: SAR 100 mg qw
n=362 Participants
Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 150 mg qw
n=365 Participants
Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 100 mg q2w
n=378 Participants
Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 150 mg q2w
Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 200 mg q2w
Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: Placebo qw
Placebo (for sarilumab) qw on top of MTX for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16
Baseline
|
1.63 units on a scale
Standard Deviation 0.63
|
1.69 units on a scale
Standard Deviation 0.63
|
1.61 units on a scale
Standard Deviation 0.65
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16
Week 16
|
1.08 units on a scale
Standard Deviation 0.67
|
1.11 units on a scale
Standard Deviation 0.7
|
1.31 units on a scale
Standard Deviation 0.67
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16
Change from baseline at Week 16
|
-0.54 units on a scale
Standard Deviation 0.55
|
-0.58 units on a scale
Standard Deviation 0.63
|
-0.3 units on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: Cohort 2 ITT population and included participants with available data of mTSS at baseline and on or before Week 52.
The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method.
Outcome measures
| Measure |
Part A: SAR 100 mg qw
n=352 Participants
Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 150 mg qw
n=359 Participants
Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 100 mg q2w
n=352 Participants
Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 150 mg q2w
Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 200 mg q2w
Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: Placebo qw
Placebo (for sarilumab) qw on top of MTX for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52
Baseline
|
54.67 units on a scale
Standard Deviation 63.42
|
46.34 units on a scale
Standard Deviation 57.43
|
48.01 units on a scale
Standard Deviation 65.23
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52
Week 52
|
55.57 units on a scale
Standard Deviation 63.73
|
46.59 units on a scale
Standard Deviation 57.63
|
50.79 units on a scale
Standard Deviation 65.82
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52
Change from baseline at Week 52
|
0.90 units on a scale
Standard Deviation 4.66
|
0.25 units on a scale
Standard Deviation 4.61
|
2.78 units on a scale
Standard Deviation 7.73
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 52Population: ITT population which included all participants randomized after dose selection (cohort 2).
Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.
Outcome measures
| Measure |
Part A: SAR 100 mg qw
n=400 Participants
Sarilumab 100 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 150 mg qw
n=399 Participants
Sarilumab 150 mg SC injection qw on top of MTX for 12 weeks.
|
Part A: SAR 100 mg q2w
n=398 Participants
Sarilumab 100 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 150 mg q2w
Sarilumab 150 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: SAR 200 mg q2w
Sarilumab 200 mg SC injection q2w alternating with placebo on top of MTX for 12 weeks.
|
Part A: Placebo qw
Placebo (for sarilumab) qw on top of MTX for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52
|
12.8 Percentage of participants
|
14.8 Percentage of participants
|
3 Percentage of participants
|
—
|
—
|
—
|
Adverse Events
Part A: SAR 100 mg qw
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Part A: SAR 150 mg qw
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Part A: SAR 100 mg q2w
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Part A: SAR 150 mg q2w
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part A: SAR 200 mg q2w
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Part A: Placebo qw
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Part B: SAR 100 mg qw Cohort 1 (Non-selected Dose)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)
Serious events: 35 serious events
Other events: 163 other events
Deaths: 0 deaths
Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)
Serious events: 46 serious events
Other events: 194 other events
Deaths: 0 deaths
Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)
Serious events: 21 serious events
Other events: 95 other events
Deaths: 0 deaths
Part B Sarilumab Rescue: Cohort 1(Selected Doses)+Cohort2
Serious events: 7 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: SAR 100 mg qw
n=50 participants at risk
Part A participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
|
Part A: SAR 150 mg qw
n=50 participants at risk
Part A participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks).
|
Part A: SAR 100 mg q2w
n=51 participants at risk
Part A participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 11 weeks).
|
Part A: SAR 150 mg q2w
n=52 participants at risk
Part A participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 12 weeks). Included the participant randomized to placebo qw who received sarilumab 150 mg q2w in error.
|
Part A: SAR 200 mg q2w
n=51 participants at risk
Part A participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 11 weeks).
|
Part A: Placebo qw
n=51 participants at risk
Part A participants exposed to placebo on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received an erroneous IMP kit with sarilumab 150 mg q2w. He/she was considered in the 150 mg q2w treatment group for safety analysis.
|
Part B: SAR 100 mg qw Cohort 1 (Non-selected Dose)
n=29 participants at risk
Part B participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
|
Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose)
n=26 participants at risk
Part B participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received sarilumab 100 mg q2w in error. He/she was considered in the 100 mg q2w treatment group for safety analysis.
|
Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose)
n=29 participants at risk
Part B participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 13 weeks). Included 1 participant who received sarilumab 100 mg q2w in error.
|
Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)
n=370 participants at risk
Part B participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 42 weeks). 61 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Included 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error.
|
Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)
n=369 participants at risk
Part B participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 42 weeks). 55 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error and included a participant randomized to placebo q2w who received sarilumab 200 mg q2w in error.
|
Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)
n=259 participants at risk
Part B participants exposed to placebo q2w on top of MTX (mean exposure of 40 weeks). 168 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 1 participant randomized to placebo q2w who received sarilumab 200 mg q2w in error. He/she was considered in the 200 mg q2w treatment group for safety analysis.
|
Part B Sarilumab Rescue: Cohort 1(Selected Doses)+Cohort2
n=284 participants at risk
Part B participants exposed to sarilumab 150 mg q2w or 200 mg q2w or placebo q2w, without adequate response from Week 16, rescued with high dose of sarilumab (SAR 200 mg q2w) (mean exposure of 49 weeks from beginning of randomization to the end of rescue treatment).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.4%
1/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.81%
3/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
1.1%
4/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.35%
1/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Abdominal wall hematoma
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Duodenal ulcer hemorrhage
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Gastric ulcer hemorrhage
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
General disorders
Immediate post-injection reaction
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
General disorders
Impaired healing
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.8%
1/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
General disorders
Pyrexia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.77%
2/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.54%
2/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.77%
2/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Bronchitis fungal
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
1.2%
3/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Endometritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.54%
2/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.35%
1/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.8%
1/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Incision site infection
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.35%
1/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.54%
2/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.35%
1/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Septic shock
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.35%
1/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Subacute endocarditis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.35%
1/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.4%
1/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.35%
1/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Wound hemorrhage
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Investigations
Transaminases increased
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.54%
2/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
1.2%
3/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.54%
2/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.35%
1/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.77%
2/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of appendix
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.8%
1/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Nervous system disorders
Ischemic stroke
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Nervous system disorders
Syncope
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Psychiatric disorders
Depression
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.54%
2/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.54%
2/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.35%
1/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.39%
1/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.54%
2/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Vascular disorders
Shock hemorrhagic
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.27%
1/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
Other adverse events
| Measure |
Part A: SAR 100 mg qw
n=50 participants at risk
Part A participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
|
Part A: SAR 150 mg qw
n=50 participants at risk
Part A participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks).
|
Part A: SAR 100 mg q2w
n=51 participants at risk
Part A participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 11 weeks).
|
Part A: SAR 150 mg q2w
n=52 participants at risk
Part A participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 12 weeks). Included the participant randomized to placebo qw who received sarilumab 150 mg q2w in error.
|
Part A: SAR 200 mg q2w
n=51 participants at risk
Part A participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 11 weeks).
|
Part A: Placebo qw
n=51 participants at risk
Part A participants exposed to placebo on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received an erroneous IMP kit with sarilumab 150 mg q2w. He/she was considered in the 150 mg q2w treatment group for safety analysis.
|
Part B: SAR 100 mg qw Cohort 1 (Non-selected Dose)
n=29 participants at risk
Part B participants exposed to sarilumab 100 mg qw on top of MTX (mean exposure of 10 weeks).
|
Part B: SAR 150 mg qw Cohort 1 (Non-selected Dose)
n=26 participants at risk
Part B participants exposed to sarilumab 150 mg qw on top of MTX (mean exposure of 12 weeks). Excluded 1 participant who received sarilumab 100 mg q2w in error. He/she was considered in the 100 mg q2w treatment group for safety analysis.
|
Part B: SAR 100 mg q2w Cohort 1 (Non-selected Dose)
n=29 participants at risk
Part B participants exposed to sarilumab 100 mg q2w on top of MTX (mean exposure of 13 weeks). Included 1 participant who received sarilumab 100 mg q2w in error.
|
Part B: SAR 150 mg q2w (Cohort 1[Selected Dose]+Cohort 2)
n=370 participants at risk
Part B participants exposed to sarilumab 150 mg q2w on top of MTX (mean exposure of 42 weeks). 61 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Included 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error.
|
Part B: SAR 200 mg q2w (Cohort 1[Selected Dose]+Cohort 2)
n=369 participants at risk
Part B participants exposed to sarilumab 200 mg q2w on top of MTX (mean exposure of 42 weeks). 55 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 3 participants randomized to sarilumab 200 mg q2w who received at least one dose of sarilumab 150 mg q2w in error and included a participant randomized to placebo q2w who received sarilumab 200 mg q2w in error.
|
Part B: Placebo q2w (Cohort 1[Selected Dose]+Cohort 2)
n=259 participants at risk
Part B participants exposed to placebo q2w on top of MTX (mean exposure of 40 weeks). 168 participants with inadequate response from Week 16 rescued with high dose of sarilumab (SAR 200 mg q2w) were not included. Excluded 1 participant randomized to placebo q2w who received sarilumab 200 mg q2w in error. He/she was considered in the 200 mg q2w treatment group for safety analysis.
|
Part B Sarilumab Rescue: Cohort 1(Selected Doses)+Cohort2
n=284 participants at risk
Part B participants exposed to sarilumab 150 mg q2w or 200 mg q2w or placebo q2w, without adequate response from Week 16, rescued with high dose of sarilumab (SAR 200 mg q2w) (mean exposure of 49 weeks from beginning of randomization to the end of rescue treatment).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
12.0%
6/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
10.0%
5/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
1.9%
1/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
19.6%
10/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.4%
1/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
7.7%
2/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.4%
1/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
9.7%
36/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
14.9%
55/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
1.8%
5/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
General disorders
Injection site erythema
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.4%
1/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
11.5%
3/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
5.4%
20/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
6.5%
24/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.77%
2/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.2%
12/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
1.9%
1/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.8%
1/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.2%
12/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
5.7%
21/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.6%
12/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.5%
7/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Influenza
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.1%
15/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.0%
11/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
5.4%
14/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
1.1%
3/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.8%
2/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.8%
1/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
5.4%
20/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
5.4%
20/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.6%
12/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.6%
13/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.8%
2/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
5.9%
3/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.8%
1/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
8.4%
31/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
9.5%
35/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
6.2%
16/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.9%
14/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Infections and infestations
Urinary tract infection
|
6.0%
3/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
1.9%
1/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.4%
1/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
5.4%
20/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
6.0%
22/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.9%
10/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.8%
8/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
6.0%
3/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
5.8%
3/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
9.8%
5/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
6.9%
2/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.8%
1/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
10.3%
3/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
6.2%
23/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
7.0%
26/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
6.6%
17/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
5.3%
15/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.0%
2/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
5.8%
3/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.8%
1/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
8.4%
31/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
8.1%
30/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.2%
11/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.2%
9/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
6.0%
3/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
6.9%
2/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.54%
2/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.7%
10/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.5%
9/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.2%
12/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/50 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.9%
2/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/52 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
0.00%
0/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
2.0%
1/51 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.4%
1/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
7.7%
2/26 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
6.9%
2/29 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
4.1%
15/370 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.8%
14/369 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
3.9%
10/259 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
1.8%
5/284 • All Adverse Events (AE) were collected from signature of the informed consent form up to study completion regardless of seriousness or relationship to investigational medicinal product (IMP).
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first IMP injection up to the end of the study). Safety population defined as all randomized participants who received at least one dose of IMP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER