Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus (NCT NCT02973321)
NCT ID: NCT02973321
Last Updated: 2022-03-24
Results Overview
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based multiple imputation (MI) method under the missing not at random framework.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
296 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2022-03-24
Participant Flow
The study was conducted at 59 centers in 8 countries. A total of 539 participants were screened between 2 December 2016 and 2 June 2017, of whom, 245 participants were screen failures. Screen failures were mainly due to exclusion criteria met. The study was double-blind for SAR425899 vs placebo and open-label for active comparator liraglutide.
Total of 294 participants were randomized using interactive response technology, however 2 participants were screened failures and were randomized by error in liraglutide and SAR425899 0.20 mg groups, therefore a total of 296 participants were randomized and treated in study. Randomization was stratified by glycosylated hemoglobin(HbA1c) at screening visit(\<8% vs \>=8%) and body mass index (BMI)(\<35.0 kg/m\^2 vs \>=35.0kg/m\^2) at Day 1(start of investigational medicinal product\[IMP\]administration).
Participant milestones
| Measure |
Placebo
Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
66
|
66
|
64
|
67
|
|
Overall Study
COMPLETED
|
32
|
51
|
52
|
48
|
62
|
|
Overall Study
NOT COMPLETED
|
1
|
15
|
14
|
16
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Overall Study
Other than specified
|
0
|
5
|
3
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
10
|
11
|
13
|
3
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=33 Participants
Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
n=64 Participants
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
n=67 Participants
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
56.1 years
STANDARD_DEVIATION 11.4 • n=21 Participants
|
55.6 years
STANDARD_DEVIATION 10.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
143 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
153 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
269 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
100 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic
|
18 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
196 Participants
n=10 Participants
|
|
BMI
|
32.07 kg/m^2
STANDARD_DEVIATION 4.41 • n=5 Participants
|
33.67 kg/m^2
STANDARD_DEVIATION 5.37 • n=7 Participants
|
34.23 kg/m^2
STANDARD_DEVIATION 4.68 • n=5 Participants
|
33.63 kg/m^2
STANDARD_DEVIATION 4.35 • n=4 Participants
|
34.23 kg/m^2
STANDARD_DEVIATION 5.51 • n=21 Participants
|
33.74 kg/m^2
STANDARD_DEVIATION 4.96 • n=10 Participants
|
|
Baseline HbA1c
|
8.04 Percentage of HbA1c
STANDARD_DEVIATION 0.86 • n=5 Participants
|
7.97 Percentage of HbA1c
STANDARD_DEVIATION 0.88 • n=7 Participants
|
7.99 Percentage of HbA1c
STANDARD_DEVIATION 0.85 • n=5 Participants
|
8.14 Percentage of HbA1c
STANDARD_DEVIATION 0.94 • n=4 Participants
|
8.11 Percentage of HbA1c
STANDARD_DEVIATION 0.86 • n=21 Participants
|
8.05 Percentage of HbA1c
STANDARD_DEVIATION 0.88 • n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: Analysis was performed on Intent-to-treat (ITT) population which included all randomized participants, irrespective of compliance with the study protocol and procedures.
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based multiple imputation (MI) method under the missing not at random framework.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
n=64 Participants
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
n=67 Participants
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Change From Baseline in HbA1c to Week 26
|
-0.663 percentage of HbA1c
Standard Error 0.169
|
-1.517 percentage of HbA1c
Standard Error 0.137
|
-1.618 percentage of HbA1c
Standard Error 0.133
|
-1.562 percentage of HbA1c
Standard Error 0.131
|
-1.312 percentage of HbA1c
Standard Error 0.118
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Analysis was performed on ITT population.
Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing post- baseline values were imputed by placebo control-based MI method under the missing not at random framework.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
n=64 Participants
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
n=67 Participants
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Body Weight to Week 26
|
-1.759 Kg
Standard Error 0.734
|
-4.276 Kg
Standard Error 0.564
|
-5.330 Kg
Standard Error 0.549
|
-4.407 Kg
Standard Error 0.559
|
-4.590 Kg
Standard Error 0.521
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis was performed on ITT population.
The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
n=64 Participants
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
n=67 Participants
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Percentage of Participants Reached HbA1c Target of <6.5% or <7% at Week 26
Participants with HbA1c Target of <6.5%
|
12.1 percentage of participants
|
47.0 percentage of participants
|
51.5 percentage of participants
|
48.4 percentage of participants
|
44.8 percentage of participants
|
|
Percentage of Participants Reached HbA1c Target of <6.5% or <7% at Week 26
Participants with HbA1c Target of <7%
|
36.4 percentage of participants
|
66.7 percentage of participants
|
68.2 percentage of participants
|
65.6 percentage of participants
|
67.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: Analysis was performed on ITT population.
The analysis included assessment collected during the study, including those obtained after IMP discontinuation or introduction of rescue therapy. Participants with no measurement at Week 26 were treated as non-responders.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
n=64 Participants
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
n=67 Participants
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving >=5% or >=10% Body Weight Loss at Week 26
Participants Achieving >=10% Body Weight Loss
|
0.0 percentage of participants
|
12.1 percentage of participants
|
13.6 percentage of participants
|
15.6 percentage of participants
|
9.0 percentage of participants
|
|
Percentage of Participants Achieving >=5% or >=10% Body Weight Loss at Week 26
Participants Achieving >=5% Body Weight Loss
|
3.0 percentage of participants
|
33.3 percentage of participants
|
45.5 percentage of participants
|
35.9 percentage of participants
|
40.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Analysis was performed on ITT population.
Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing post-baseline values were imputed by placebo control-based MI method under the missing not at random framework.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
n=64 Participants
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
n=67 Participants
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26
|
-0.931 mmol/L
Standard Error 0.394
|
-2.408 mmol/L
Standard Error 0.308
|
-2.548 mmol/L
Standard Error 0.301
|
-2.318 mmol/L
Standard Error 0.312
|
-2.124 mmol/L
Standard Error 0.280
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Analysis was performed on ITT population. Overall number of participants analyzed = participants with at least 1 baseline and 1 post-baseline SMPG assessment during 26 week treatment period.
Change in 7-point SMPG profile from baseline to Week 26 was assessed by summary statistics. 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, and Week 26): pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) is defined as 2 hours after the start of the meal.
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
n=40 Participants
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
n=43 Participants
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
n=44 Participants
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
n=49 Participants
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26
|
-1.82 mmol/L
Standard Deviation 3.11
|
-2.86 mmol/L
Standard Deviation 2.62
|
-2.63 mmol/L
Standard Deviation 2.70
|
-2.49 mmol/L
Standard Deviation 3.18
|
-2.21 mmol/L
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: Baseline up to 26 weeksPopulation: Analysis was performed on ITT population.
Rescue medication was introduced in case FPG or HbA1c values were above pre-defined thresholds, and if no reasons were found for insufficient glucose control, and appropriate action failed to decrease FPG / HbA1c under the threshold values (from baseline to Week 8: FPG \>270 mg/dL 15.0 mmol/L, from Week 8 to Week 14: FPG \>13.3 mmol/L, and from Week 14 to Week 26: FPG \>11.1 mmol/L or HbA1c\>8%). The choice of rescue therapy was at the Investigator's discretion with the exception of using glucagon-like peptide-1 receptor (GLP-1R) agonists or dipeptidyl peptidase 4 (DPP4) inhibitors.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
n=64 Participants
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
n=67 Participants
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Percentage of Participants Requiring Rescue Therapy
|
18.2 percentage of participants
|
0.0 percentage of participants
|
1.5 percentage of participants
|
3.1 percentage of participants
|
6.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Analysis was performed on ITT population.
Beta-cell function was assessed by homeostatic model assessment (HOMA)-beta, derived from FPG and fasting plasma insulin (FPI). HOMA-beta was derived from FPG and FPI as (20\*FPI \[micro units/milliliter\]) divided by (FPG \[mmol/L\] minus 3.5). Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value\*100.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
n=64 Participants
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
n=67 Participants
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Change From Baseline in Beta-Cell Function to Week 26
|
15.025 percentage of normal beta cells function
Standard Error 19.785
|
26.768 percentage of normal beta cells function
Standard Error 15.833
|
31.122 percentage of normal beta cells function
Standard Error 16.467
|
17.932 percentage of normal beta cells function
Standard Error 14.397
|
27.263 percentage of normal beta cells function
Standard Error 13.234
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Analysis was performed on ITT population.
Insulin Resistance was assessed by homeostasis model assessment for insulin resistance (HOMA-IR), derived from FPG and FPI. HOMA-IR was derived from FPG and FPI as (FPI \[micro units per milliliter\] \* FPG \[mmol/L\]) divided by 22.5. Change was calculated for HOMA-beta by subtracting the Baseline value from Week 26 value.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
n=64 Participants
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
n=67 Participants
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Change From Baseline in Insulin Resistance to Week 26
|
-1.315 HOMA-IR Index
Standard Error 0.865
|
-1.244 HOMA-IR Index
Standard Error 0.670
|
-2.233 HOMA-IR Index
Standard Error 0.664
|
-2.324 HOMA-IR Index
Standard Error 0.649
|
-1.405 HOMA-IR Index
Standard Error 0.613
|
SECONDARY outcome
Timeframe: Baseline,Week 26Population: Analysis was performed on ITT population.
Waist circumference was measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, using a stretch-resistant tape providing a constant 100 gm tension. Hip circumference was measured around the widest portion of the buttocks, with the tape parallel to the floor. Each measurement was repeated twice; if the measurements were within 1 cm of one another, the average was calculated, and if the difference exceeded 1 cm, the measurements were repeated.
Outcome measures
| Measure |
Placebo
n=33 Participants
Placebo (for SAR425899) SC injection QD from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.12 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.12 mg for 25 weeks (Week 2 to Week 26) following 1 week dose increase step (0.06 mg at Week 1).
|
SAR425899 0.16 mg
n=66 Participants
SAR425899 SC injection QD at maintenance dose of 0.16 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase step (0.06 mg at Week 1 and 0.12 mg at Week 2).
|
SAR425899 0.20 mg
n=64 Participants
SAR425899 SC injection QD at maintenance dose of 0.20 mg for 23 weeks (Week 4 to Week 26) following 3 weeks dose increase step (0.06 mg at Week 1, 0.12 mg at Week 2 and 0.16 mg at Week 3).
|
Liraglutide
n=67 Participants
Liraglutide SC injection QD at maintenance dose of 1.8 mg for 24 weeks (Week 3 to Week 26) following 2 weeks dose increase steps (0.6 mg daily at Week 1 and by 1.2 mg daily at Week 2).
|
|---|---|---|---|---|---|
|
Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences
Waist Circumference
|
-2.0 cm
Standard Error 0.75
|
-5.3 cm
Standard Error 1.34
|
-2.3 cm
Standard Error 1.61
|
-3.2 cm
Standard Error 0.66
|
-4.0 cm
Standard Error 2.03
|
|
Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences
Hip Circumference
|
-1.42 cm
Standard Error 0.781
|
-4.46 cm
Standard Error 1.378
|
-1.97 cm
Standard Error 1.572
|
-4.09 cm
Standard Error 0.945
|
-2.56 cm
Standard Error 1.513
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
SAR425899 0.06 mg
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
SAR425899 0.12 mg
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
SAR425899 0.16 mg
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
SAR425899 0.20 mg
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Liraglutide
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=33 participants at risk
Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.06 mg
n=18 participants at risk
Participants who were originally randomized to SAR425899 treatment groups and received 0.06 mg QD at Week 8.
|
SAR425899 0.12 mg
n=72 participants at risk
Participants who were originally randomized to SAR425899 treatment groups and received 0.12 mg QD at Week 8, or participants randomized to SAR425899 0.12 mg treatment group and discontinued the study before Week 8.
|
SAR425899 0.16 mg
n=59 participants at risk
Participants who were originally randomized to SAR425899 treatment groups and received 0.16 mg QD at Week 8, or participants randomized to SAR425899 0.16 mg treatment group and discontinued the study before Week 8.
|
SAR425899 0.20 mg
n=47 participants at risk
Participants who were originally randomized to SAR425899 treatment groups and received 0.20 mg QD at Week 8, or participants randomized to SAR425899 0.20 mg treatment group and discontinued the study before Week 8.
|
Liraglutide
n=67 participants at risk
Participants randomized to and received Liraglutide treatment were included in the Liraglutide treatment arm regardless of dose amount participants received.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Pancreatic Cyst
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Infections and infestations
Cellulitis Staphylococcal
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.4%
1/72 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
2.1%
1/47 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
2.1%
1/47 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Adrenals
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.4%
1/72 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Nervous system disorders
Hypoglycaemic Unconsciousness
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.7%
1/59 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Nervous system disorders
Loss Of Consciousness
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.7%
1/59 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.4%
1/72 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
Other adverse events
| Measure |
Placebo
n=33 participants at risk
Placebo (for SAR425899) subcutaneous (SC) injection once daily (QD) from Week 1 to Week 26, matching 3 SAR425899 dose levels of 0.12 mg, 0.16 mg and 0.20 mg.
|
SAR425899 0.06 mg
n=18 participants at risk
Participants who were originally randomized to SAR425899 treatment groups and received 0.06 mg QD at Week 8.
|
SAR425899 0.12 mg
n=72 participants at risk
Participants who were originally randomized to SAR425899 treatment groups and received 0.12 mg QD at Week 8, or participants randomized to SAR425899 0.12 mg treatment group and discontinued the study before Week 8.
|
SAR425899 0.16 mg
n=59 participants at risk
Participants who were originally randomized to SAR425899 treatment groups and received 0.16 mg QD at Week 8, or participants randomized to SAR425899 0.16 mg treatment group and discontinued the study before Week 8.
|
SAR425899 0.20 mg
n=47 participants at risk
Participants who were originally randomized to SAR425899 treatment groups and received 0.20 mg QD at Week 8, or participants randomized to SAR425899 0.20 mg treatment group and discontinued the study before Week 8.
|
Liraglutide
n=67 participants at risk
Participants randomized to and received Liraglutide treatment were included in the Liraglutide treatment arm regardless of dose amount participants received.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.4%
1/72 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
3.4%
2/59 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
11.1%
2/18 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
8.5%
5/59 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
2.1%
1/47 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.0%
1/33 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.4%
1/72 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.1%
3/59 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
10.6%
5/47 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
3.0%
2/67 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
4.2%
3/72 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
6.8%
4/59 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
4.3%
2/47 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Chronic Gastritis
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Constipation
|
3.0%
1/33 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
6.9%
5/72 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
10.2%
6/59 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
6.4%
3/47 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
3.0%
2/67 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
2/33 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
38.9%
7/18 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
20.8%
15/72 • Number of events 23 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
18.6%
11/59 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
19.1%
9/47 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
11.9%
8/67 • Number of events 10 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
33.3%
6/18 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
18.1%
13/72 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
6.8%
4/59 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
6.4%
3/47 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
7.5%
5/67 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
11.1%
2/18 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.4%
1/72 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
3.4%
2/59 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
2.1%
1/47 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
4/72 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
3.4%
2/59 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
2.1%
1/47 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
4.5%
3/67 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
16.7%
3/18 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
2.8%
2/72 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
4.3%
2/47 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Nausea
|
15.2%
5/33 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
72.2%
13/18 • Number of events 22 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
45.8%
33/72 • Number of events 45 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
55.9%
33/59 • Number of events 41 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
55.3%
26/47 • Number of events 36 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
31.3%
21/67 • Number of events 25 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Pyloric Sphincter Insufficiency
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
55.6%
10/18 • Number of events 17 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
29.2%
21/72 • Number of events 32 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
23.7%
14/59 • Number of events 23 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
36.2%
17/47 • Number of events 24 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
General disorders
Asthenia
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.4%
1/72 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.7%
1/59 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
2.1%
1/47 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
General disorders
Fatigue
|
3.0%
1/33 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.4%
1/72 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
3.4%
2/59 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
10.6%
5/47 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
4.5%
3/67 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
General disorders
Injection Site Pain
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
General disorders
Injection Site Reaction
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.4%
1/72 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
General disorders
Pyrexia
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
2.1%
1/47 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
2.1%
1/47 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.1%
2/33 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
3.4%
2/59 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.7%
1/59 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Investigations
Lipase Increased
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.4%
1/72 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
6.4%
3/47 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.5%
1/67 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Investigations
Weight Decreased
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.0%
1/33 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
11.1%
2/18 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
4/72 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
8.5%
5/59 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
8.5%
4/47 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
4.5%
3/67 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Nervous system disorders
Dizziness
|
6.1%
2/33 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/18 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
4/72 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.1%
3/59 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
2.1%
1/47 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
3.0%
2/67 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
16.7%
3/18 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
6.9%
5/72 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
1.7%
1/59 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
2.1%
1/47 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
4.5%
3/67 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Vascular disorders
Aortic Arteriosclerosis
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
|
Vascular disorders
Hot Flush
|
0.00%
0/33 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
5.6%
1/18 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/72 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/59 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/47 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
0.00%
0/67 • All Adverse Events (AEs) were collected from signature of the informed consent form until 3 days after last treatment administration (Day 185).
Reported AEs were treatment-emergent AEs that is AEs that developed/worsened or became serious during the 26-week'treatment period' (Treatment period was defined as time from the first injection of IMP up to last injection of IMP + 3 days). AE data was planned to be reported based on the dose received starting at Week 8 when adjustment of dose was not allowed (or randomized treatment arm if participant discontinued before Week 8).
|
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