Trial Outcomes & Findings for A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight (NCT NCT06230523)
NCT ID: NCT06230523
Last Updated: 2026-06-24
Results Overview
Least squares (LS) means were calculated using a mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time\*Sex +Time\*Baseline BMI Category + Treatment\*Time + Time\*Baseline. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
263 participants
Primary outcome timeframe
Baseline, Week 48
Results posted on
2026-06-24
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received subcutaneous (SC) injections of eloralintide-matching placebo administered once weekly (QW) for 48 weeks.
|
1 mg Eloralintide
Participants received eloralintide 1 milligram (mg) SC QW for 48 weeks.
|
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
28
|
24
|
28
|
54
|
24
|
52
|
|
Overall Study
COMPLETED
|
38
|
15
|
19
|
21
|
48
|
19
|
46
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
5
|
7
|
6
|
5
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Participants received subcutaneous (SC) injections of eloralintide-matching placebo administered once weekly (QW) for 48 weeks.
|
1 mg Eloralintide
Participants received eloralintide 1 milligram (mg) SC QW for 48 weeks.
|
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
1
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
2
|
3
|
2
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
2
|
3
|
2
|
3
|
3
|
|
Overall Study
Other
|
1
|
1
|
1
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
Baseline characteristics by cohort
| Measure |
6/9 mg Eloralintide
n=24 Participants
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
9 mg Eloralintide
n=54 Participants
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
Placebo
n=53 Participants
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
|
1 mg Eloralintide
n=28 Participants
Participants received eloralintide 1 mg SC QW for 48 weeks.
|
3 mg Eloralintide
n=24 Participants
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
n=28 Participants
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
3/6/9 mg Eloralintide
n=52 Participants
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.10 years
STANDARD_DEVIATION 10.93 • n=13 Participants
|
50.20 years
STANDARD_DEVIATION 12.34 • n=7 Participants
|
48.80 years
STANDARD_DEVIATION 12.30 • n=20 Participants
|
50.40 years
STANDARD_DEVIATION 13.93 • n=20 Participants
|
48.60 years
STANDARD_DEVIATION 12.17 • n=40 Participants
|
46.10 years
STANDARD_DEVIATION 14.57 • n=6 Participants
|
48.70 years
STANDARD_DEVIATION 12.89 • n=6 Participants
|
49.00 years
STANDARD_DEVIATION 12.65 • n=6 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=13 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
21 Participants
n=6 Participants
|
41 Participants
n=6 Participants
|
204 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=13 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
7 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
59 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=13 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
41 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=13 Participants
|
44 Participants
n=7 Participants
|
43 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
27 Participants
n=6 Participants
|
42 Participants
n=6 Participants
|
222 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=13 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
48 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=13 Participants
|
39 Participants
n=7 Participants
|
41 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
24 Participants
n=6 Participants
|
39 Participants
n=6 Participants
|
205 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=13 Participants
|
54 Participants
n=7 Participants
|
53 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
28 Participants
n=6 Participants
|
52 Participants
n=6 Participants
|
263 Participants
n=6 Participants
|
|
Body Weight
|
110.03 Kilograms (Kg)
STANDARD_DEVIATION 24.55 • n=13 Participants
|
106.99 Kilograms (Kg)
STANDARD_DEVIATION 17.17 • n=7 Participants
|
109.02 Kilograms (Kg)
STANDARD_DEVIATION 21.96 • n=20 Participants
|
113.02 Kilograms (Kg)
STANDARD_DEVIATION 34.96 • n=20 Participants
|
107.75 Kilograms (Kg)
STANDARD_DEVIATION 18.97 • n=40 Participants
|
106.94 Kilograms (Kg)
STANDARD_DEVIATION 18.15 • n=6 Participants
|
110.76 Kilograms (Kg)
STANDARD_DEVIATION 24.18 • n=6 Participants
|
109.13 Kilograms (Kg)
STANDARD_DEVIATION 22.75 • n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: All randomized participants who had evaluable data for this specific outcome.
Least squares (LS) means were calculated using a mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time\*Sex +Time\*Baseline BMI Category + Treatment\*Time + Time\*Baseline. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Outcome measures
| Measure |
6/9 mg Eloralintide
n=24 Participants
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
Placebo
n=53 Participants
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
|
1 mg Eloralintide
n=28 Participants
Participants received eloralintide 1 mg SC QW for 48 weeks.
|
3 mg Eloralintide
n=24 Participants
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
n=28 Participants
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
9 mg Eloralintide
n=54 Participants
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
3/6/9 mg Eloralintide
n=52 Participants
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 48
|
-19.9 percent change
Standard Error 1.45
|
-0.4 percent change
Standard Error 0.91
|
-9.4 percent change
Standard Error 1.60
|
-12.4 percent change
Standard Error 1.30
|
-17.6 percent change
Standard Error 1.56
|
-20.1 percent change
Standard Error 1.31
|
-16.5 percent change
Standard Error 1.18
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: All randomized participants who had evaluable data for this specific outcome.
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time\*Sex +Time\*Baseline BMI Category + Treatment\*Time + Time\*Baseline. Variance-Covariance structure (Change from Baseline) = Unstructured.
Outcome measures
| Measure |
6/9 mg Eloralintide
n=24 Participants
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
Placebo
n=53 Participants
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
|
1 mg Eloralintide
n=28 Participants
Participants received eloralintide 1 mg SC QW for 48 weeks.
|
3 mg Eloralintide
n=24 Participants
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
n=28 Participants
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
9 mg Eloralintide
n=54 Participants
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
3/6/9 mg Eloralintide
n=52 Participants
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 48
|
-21.0 Kilograms (Kg)
Standard Error 1.46
|
-0.2 Kilograms (Kg)
Standard Error 1.01
|
-10.2 Kilograms (Kg)
Standard Error 1.66
|
-13.3 Kilograms (Kg)
Standard Error 1.37
|
-18.7 Kilograms (Kg)
Standard Error 1.81
|
-21.3 Kilograms (Kg)
Standard Error 1.41
|
-18.0 Kilograms (Kg)
Standard Error 1.37
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: All randomized participants who had evaluable data for this specific outcome.
Mean percentage of participants who achieved ≥5% body weight reduction was analysed by logistic regression model with multiple imputation. Model: Variable = Baseline + Treatment + Sex + Baseline BMI Category. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 48 in imputed data sets using Rubin's rule.
Outcome measures
| Measure |
6/9 mg Eloralintide
n=24 Participants
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
Placebo
n=53 Participants
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
|
1 mg Eloralintide
n=28 Participants
Participants received eloralintide 1 mg SC QW for 48 weeks.
|
3 mg Eloralintide
n=24 Participants
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
n=28 Participants
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
9 mg Eloralintide
n=54 Participants
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
3/6/9 mg Eloralintide
n=52 Participants
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Percentage of Participants Who Achieved Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline to Week 48
|
97.50 percentage of participants
Standard Error 4.00
|
31.21 percentage of participants
Standard Error 7.19
|
71.55 percentage of participants
Standard Error 9.81
|
87.12 percentage of participants
Standard Error 7.75
|
84.99 percentage of participants
Standard Error 8.04
|
92.72 percentage of participants
Standard Error 4.07
|
90.80 percentage of participants
Standard Error 4.78
|
SECONDARY outcome
Timeframe: Baseline to Week 48Population: All randomized participants who had evaluable data for this specific outcome.
Mean percentage of participants who achieved ≥10% body weight reduction was analysed by logistic regression model with multiple imputation. Model: Variable = Baseline + Treatment + Sex + Baseline BMI Category. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 48 in imputed data sets using Rubin's rule.
Outcome measures
| Measure |
6/9 mg Eloralintide
n=24 Participants
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
Placebo
n=53 Participants
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
|
1 mg Eloralintide
n=28 Participants
Participants received eloralintide 1 mg SC QW for 48 weeks.
|
3 mg Eloralintide
n=24 Participants
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
n=28 Participants
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
9 mg Eloralintide
n=54 Participants
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
3/6/9 mg Eloralintide
n=52 Participants
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Mean Percentage of Participants Who Achieved ≥ 10% Body Weight Reduction From Baseline to Week 48
|
91.13 percentage of participants
Standard Error 6.33
|
12.85 percentage of participants
Standard Error 5.37
|
53.25 percentage of participants
Standard Error 10.76
|
60.45 percentage of participants
Standard Error 11.06
|
76.57 percentage of participants
Standard Error 9.27
|
82.32 percentage of participants
Standard Error 5.55
|
79.24 percentage of participants
Standard Error 6.17
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: All randomized participants who had evaluable data for this specific outcome.
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time\*Sex +Time\*Baseline BMI Category + Treatment\*Time + Time\*Baseline. Variance-Covariance structure (Change from Baseline) = Unstructured.
Outcome measures
| Measure |
6/9 mg Eloralintide
n=24 Participants
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
Placebo
n=53 Participants
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
|
1 mg Eloralintide
n=28 Participants
Participants received eloralintide 1 mg SC QW for 48 weeks.
|
3 mg Eloralintide
n=24 Participants
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
n=28 Participants
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
9 mg Eloralintide
n=54 Participants
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
3/6/9 mg Eloralintide
n=52 Participants
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Mass Index (BMI) at Week 48
|
-7.8 kilogram per square metre (kg/m^2)
Standard Error 0.60
|
-0.2 kilogram per square metre (kg/m^2)
Standard Error 0.37
|
-3.7 kilogram per square metre (kg/m^2)
Standard Error 0.58
|
-4.7 kilogram per square metre (kg/m^2)
Standard Error 0.50
|
-6.7 kilogram per square metre (kg/m^2)
Standard Error 0.65
|
-7.7 kilogram per square metre (kg/m^2)
Standard Error 0.50
|
-6.4 kilogram per square metre (kg/m^2)
Standard Error 0.47
|
SECONDARY outcome
Timeframe: Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 36; Post dose (2 to 6 hours after dosing) at Week 0, Week 24; Post dose (24 to 72 hours after dosing) at Week 12; random at Week 48Population: All randomized participants who had evaluable data for this specific PK outcome.Dose-escalation arms (6/9 mg and 3/6/9 mg) are not included as separate columns, as their steady-state PK exposures are consistent with 9 mg QW and have been pooled into the 9 mg eloralintide arm.
PK samples were analyzed using a population PK model approach to estimate AUC at steady state. Data presented are Geometric Mean with 90% prediction interval (PI).
Outcome measures
| Measure |
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
Placebo
n=27 Participants
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
|
1 mg Eloralintide
n=23 Participants
Participants received eloralintide 1 mg SC QW for 48 weeks.
|
3 mg Eloralintide
n=28 Participants
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
n=127 Participants
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Curve (AUC) of Eloralintide at Steady State
|
—
|
47300 nanogram*hour per milliliter (ng*h/mL)
90% prediction interval (24600 to 90700)
|
148000 nanogram*hour per milliliter (ng*h/mL)
90% prediction interval (71700 to 291000)
|
306000 nanogram*hour per milliliter (ng*h/mL)
90% prediction interval (151000 to 621000)
|
468000 nanogram*hour per milliliter (ng*h/mL)
90% prediction interval (237000 to 997000)
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 36; Post dose (2 to 6 hours after dosing) at Week 0, Week 24; Post dose (24 to 72 hours after dosing) at Week 12; random at Week 48Population: All randomized participants who had evaluable data for this specific PK outcome.Dose-escalation arms (6/9 mg and 3/6/9 mg) are not included as separate columns, as their steady-state PK exposures are consistent with 9 mg QW and have been pooled into the 9 mg eloralintide arm.
PK samples were analyzed using a population PK model approach to estimate Cmax at steady state. Data presented are Geometric Mean with 90% prediction interval (PI).
Outcome measures
| Measure |
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
Placebo
n=27 Participants
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
|
1 mg Eloralintide
n=23 Participants
Participants received eloralintide 1 mg SC QW for 48 weeks.
|
3 mg Eloralintide
n=28 Participants
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
n=127 Participants
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Eloralintide at Steady State
|
—
|
322 nanogram per milliliter (ng/mL)
90% prediction interval (179 to 587)
|
1010 nanogram per milliliter (ng/mL)
90% prediction interval (524 to 1880)
|
2090 nanogram per milliliter (ng/mL)
90% prediction interval (1090 to 4080)
|
3210 nanogram per milliliter (ng/mL)
90% prediction interval (1690 to 6460)
|
—
|
—
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
1 mg Eloralintide
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
3 mg Eloralintide
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
6 mg Eloralintide
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
9 mg Eloralintide
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
6/9 mg Eloralintide
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
3/6/9 mg Eloralintide
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=53 participants at risk
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
|
1 mg Eloralintide
n=28 participants at risk
Participants received eloralintide 1 mg SC QW for 48 weeks.
|
3 mg Eloralintide
n=24 participants at risk
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
n=28 participants at risk
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
9 mg Eloralintide
n=54 participants at risk
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
6/9 mg Eloralintide
n=24 participants at risk
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
3/6/9 mg Eloralintide
n=52 participants at risk
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Diverticulitis meckel's
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/54 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Mastoiditis
|
1.9%
1/53 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
1.9%
1/53 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma recurrent
|
1.9%
1/53 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/54 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/54 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/40 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/41 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/54 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
1/53 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=53 participants at risk
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
|
1 mg Eloralintide
n=28 participants at risk
Participants received eloralintide 1 mg SC QW for 48 weeks.
|
3 mg Eloralintide
n=24 participants at risk
Participants received eloralintide 3 mg SC QW for 48 weeks.
|
6 mg Eloralintide
n=28 participants at risk
Participants received eloralintide 6 mg SC QW for 48 weeks.
|
9 mg Eloralintide
n=54 participants at risk
Participants received eloralintide 9 mg SC QW for 48 weeks.
|
6/9 mg Eloralintide
n=24 participants at risk
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
|
3/6/9 mg Eloralintide
n=52 participants at risk
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
2/54 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.7%
3/28 • Number of events 4 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
3/54 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Visual impairment
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
5.7%
3/53 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
4/28 • Number of events 4 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
4/24 • Number of events 4 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
24.1%
13/54 • Number of events 15 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
4/24 • Number of events 4 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
4/52 • Number of events 5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
5/53 • Number of events 5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
35.7%
10/28 • Number of events 10 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
6/54 • Number of events 6 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
3/24 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.3%
9/52 • Number of events 9 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Eructation
|
1.9%
1/53 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Faeces soft
|
5.7%
3/53 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
1.9%
1/53 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
13.2%
7/53 • Number of events 12 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.7%
3/28 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
3/24 • Number of events 7 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
64.3%
18/28 • Number of events 23 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
33.3%
18/54 • Number of events 19 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
54.2%
13/24 • Number of events 17 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
13/52 • Number of events 15 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
7/28 • Number of events 14 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
6/54 • Number of events 8 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.7%
4/24 • Number of events 6 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Early satiety
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
11.3%
6/53 • Number of events 6 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
3/24 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
28.6%
8/28 • Number of events 9 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
42.6%
23/54 • Number of events 31 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
45.8%
11/24 • Number of events 12 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.2%
11/52 • Number of events 12 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
5.7%
3/53 • Number of events 19 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
3/54 • Number of events 11 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
3/24 • Number of events 6 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
4/52 • Number of events 18 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Thirst
|
1.9%
1/53 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
3.8%
2/53 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
4/28 • Number of events 4 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.7%
3/28 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.6%
5/52 • Number of events 5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
1.9%
1/53 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.7%
3/28 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/54 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/13 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
3/54 • Number of events 4 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.3%
6/53 • Number of events 6 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.8%
5/24 • Number of events 5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.8%
3/52 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
3/53 • Number of events 5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
3/54 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/40 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/41 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Lipase increased
|
1.9%
1/53 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/54 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.8%
2/53 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
4/28 • Number of events 4 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.8%
8/54 • Number of events 8 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.6%
5/52 • Number of events 5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/54 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
3/53 • Number of events 4 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.5%
3/24 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
2/54 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/52 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
2/53 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/54 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
3.8%
2/53 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
4/54 • Number of events 5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.2%
1/24 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
2/52 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
9.4%
5/53 • Number of events 11 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.6%
3/54 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.6%
5/52 • Number of events 5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
3.8%
2/53 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/54 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
4/52 • Number of events 5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/40 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/41 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
15.4%
2/13 • Number of events 3 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Prostatitis
|
7.7%
1/13 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/7 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/28 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
2/28 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
1/54 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/52 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/53 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.6%
1/28 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
6/54 • Number of events 6 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
2/24 • Number of events 2 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.6%
5/52 • Number of events 5 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Social circumstances
Menopause
|
0.00%
0/40 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/21 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/43 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/41 • Baseline to end of safety follow-up (up to 58 weeks)
* All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60