Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease (NCT NCT04844918)
NCT ID: NCT04844918
Last Updated: 2024-07-16
Results Overview
Mean percent change in body weight was measured. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + impaired glucose tolerance (IGT) at Screening + Hyperlipidemia at Screening + non-alcoholic fatty liver disease (NAFLD) at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
267 participants
Primary outcome timeframe
Baseline, 72 Weeks
Results posted on
2024-07-16
Participant Flow
267 participants were randomized in the study. However, due to good clinical practice (GCP) compliance issues identified at one of the investigative sites, all 42 participants from that site were excluded from the study analyses
Participant milestones
| Measure |
10 Milligrams (mg) Tirzepatide
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).
|
15 mg Tirzepatide
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Overall Study
STARTED
|
88
|
90
|
89
|
|
Overall Study
Received At Least 1 Dose of Study Drug (Excluding the GCP Compliance Investigative Site)
|
73
|
77
|
75
|
|
Overall Study
COMPLETED
|
60
|
65
|
67
|
|
Overall Study
NOT COMPLETED
|
28
|
25
|
22
|
Reasons for withdrawal
| Measure |
10 Milligrams (mg) Tirzepatide
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).
|
15 mg Tirzepatide
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
8
|
5
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
3
|
|
Overall Study
Participants Excluded Due to GCP Compliance Issue
|
15
|
13
|
14
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease
Baseline characteristics by cohort
| Measure |
10 mg Tirzepatide
n=73 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=77 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=75 Participants
Participants received matching placebo administered SC QW.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.00 years
STANDARD_DEVIATION 10.87 • n=99 Participants
|
51.10 years
STANDARD_DEVIATION 10.30 • n=107 Participants
|
52.30 years
STANDARD_DEVIATION 10.93 • n=206 Participants
|
50.80 years
STANDARD_DEVIATION 10.74 • n=7 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
92 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
133 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
73 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
225 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
73 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
225 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Japan
|
73 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
225 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, 72 WeeksPopulation: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Mean percent change in body weight was measured. Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with Baseline + impaired glucose tolerance (IGT) at Screening + Hyperlipidemia at Screening + non-alcoholic fatty liver disease (NAFLD) at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=59 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=65 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=66 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Mean Percent Change in Body Weight
|
-17.8 Percent change
Standard Error 0.94
|
-22.7 Percent change
Standard Error 0.90
|
-1.7 Percent change
Standard Error 0.90
|
PRIMARY outcome
Timeframe: Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug, had a baseline and at least one post-baseline value for this outcome.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Outcome measures
| Measure |
10 mg Tirzepatide
n=71 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=76 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=75 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
|
94.37 Percentage of participants
|
96.05 Percentage of participants
|
20 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and evaluable data for this outcome.
Percentage of participants who had improvement in obesity-related health problems
Outcome measures
| Measure |
10 mg Tirzepatide
n=60 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=64 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=63 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Had Improvement in Obesity-related Health Problems
|
70.0 Percentage of participants
|
79.69 Percentage of participants
|
11.11 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome.
Change from Baseline in Fasting Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=35 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=40 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=47 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Fasting Glucose for Participants With IGT at Baseline
|
-12.81 milligrams per deciliter (mg/dL)
Standard Error 1.490
|
-10.61 milligrams per deciliter (mg/dL)
Standard Error 1.391
|
2.19 milligrams per deciliter (mg/dL)
Standard Error 1.291
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome.
Change from Baseline in OGTT 2-hr Glucose for Participants with IGT at Baseline. LS mean was determined by MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=35 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=40 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=47 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline
|
-61.50 milligrams per deciliter (mg/dL)
Standard Error 5.330
|
-70.56 milligrams per deciliter (mg/dL)
Standard Error 4.951
|
-5.74 milligrams per deciliter (mg/dL)
Standard Error 4.612
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who had hyperlipidemia at baseline, received at least one dose of study drug and had evaluable data for this outcome.
Percent Change from Baseline in Fasting Lipids TG for Participants with Hyperlipidemia at Baseline. LS mean was determined by MMRM model with log (Baseline) + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=29 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=37 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=36 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline
|
-47.3 Percent change
Standard Error 3.34
|
-50.6 Percent change
Standard Error 2.77
|
-11.0 Percent change
Standard Error 5.14
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who were diagnosed as NAFLD by MRI at baseline and received at least one dose of study drug and had evaluable data for this outcome.
Percent Change from Baseline in HFF for participants diagnosed as NAFLD by MRI at Baseline. LS mean was determined by ANCOVA model with Baseline + Hyperlipidemia at Screening + IGT at Screening + Sex + Treatment (Type III sum of squares) as variables. Percent Change from Baseline in HFF for participants with NAFLD is reported. NAFLD was diagnosed by Magnetic Resonance Imaging (MRI) at Baseline. This was evaluated only for participants who were diagnosed with NAFLD at baseline by MRI.
Outcome measures
| Measure |
10 mg Tirzepatide
n=59 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=62 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=61 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]
|
-63.9 Percent change
Standard Error 3.09
|
-69.9 Percent change
Standard Error 2.99
|
-19.6 Percent change
Standard Error 3.05
|
SECONDARY outcome
Timeframe: Week 72Population: All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome.
Percentage of Participants Who Achieved Improvements of IGT. This was evaluated only for participants with IGT at baseline.
Outcome measures
| Measure |
10 mg Tirzepatide
n=40 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=46 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=50 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Improvements of IGT
|
92.50 Percentage of participants
|
97.83 Percentage of participants
|
28.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: All participants, excluding the GCP compliance investigative site, with hyperlipidemia at baseline, received at least one dose of study drug and had evaluable data for this outcome.
Percentage of Participants Who Achieved Improvements of Hyperlipidemia. This was evaluated only for participants with hyperlipidemia at baseline.
Outcome measures
| Measure |
10 mg Tirzepatide
n=29 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=37 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=36 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Improvements of Hyperlipidemia
|
72.41 Percentage of participants
|
81.08 Percentage of participants
|
25 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: All participants, excluding the GCP compliance investigative site, diagnosed as NAFLD by MRI at baseline, received at least one dose of study drug, and had evaluable data for this outcome.
Percentage of Participants Who Achieved Improvements of NAFLD. This was evaluated only for participants who were diagnosed as NAFLD by MRI at Baseline.
Outcome measures
| Measure |
10 mg Tirzepatide
n=59 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=62 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=61 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Improvements of NAFLD
|
69.49 Percentage of participants
|
77.42 Percentage of participants
|
9.84 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of Participants Who Achieve ≥10% body weight reduction.
Outcome measures
| Measure |
10 mg Tirzepatide
n=71 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=76 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=75 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
|
85.92 Percentage of participants
|
92.11 Percentage of participants
|
4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of Participants Who Achieve ≥15% body weight reduction.
Outcome measures
| Measure |
10 mg Tirzepatide
n=71 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=76 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=75 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
|
63.38 Percentage of participants
|
82.89 Percentage of participants
|
1.33 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Change from Baseline in Absolute Body Weight. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=59 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=65 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=66 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Absolute Body Weight
|
-16.0 kilograms (kg)
Standard Error 0.86
|
-20.8 kilograms (kg)
Standard Error 0.82
|
-1.5 kilograms (kg)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Change from Baseline in BMI. LS mean was determined using MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=59 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=65 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=66 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Body Mass Index (BMI)
|
-5.8 kilograms per metres squared (kg/m^2)
Standard Error 0.32
|
-7.7 kilograms per metres squared (kg/m^2)
Standard Error 0.30
|
-0.6 kilograms per metres squared (kg/m^2)
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Percent Change from Baseline in VAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=60 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=63 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=61 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Visceral Adipose Tissue (VAT)
|
-39.4 Percent change
Standard Error 2.44
|
-44.5 Percent change
Standard Error 2.37
|
-3.4 Percent change
Standard Error 2.42
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Percent Change from Baseline in SAT. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=60 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=63 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=61 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT)
|
-32.2 Percent change
Standard Error 1.90
|
-36.5 Percent change
Standard Error 1.85
|
-5.0 Percent change
Standard Error 1.90
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Change from Baseline in VAT/SAT Ratio. LS mean was determined by MMRM model with Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=60 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=63 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=61 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in VAT/SAT Ratio
|
-0.09 ratio
Standard Error 0.023
|
-0.08 ratio
Standard Error 0.023
|
0.01 ratio
Standard Error 0.023
|
SECONDARY outcome
Timeframe: Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Percentage of Participants Who Achieve VAT \<100 cm² from Baseline for participants with VAT≥100 cm² at Baseline.
Outcome measures
| Measure |
10 mg Tirzepatide
n=57 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=62 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=61 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline
|
26.32 Percentage of participants
|
37.10 Percentage of participants
|
1.64 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Change from Baseline in Waist Circumference. LS mean was determined using MMRM model with = Baseline + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=59 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=65 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=66 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Waist Circumference
|
-12.7 centimeters (cm)
Standard Error 0.88
|
-16.6 centimeters (cm)
Standard Error 0.83
|
-1.3 centimeters (cm)
Standard Error 0.84
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug and had evaluable data for this outcome.
Change from Baseline in HbA1c was assessed only for Participants with IGT at Baseline. LS mean was determined using MMRM model with = Baseline + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=35 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=40 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=47 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
|
-0.67 Percentage of HbA1c
Standard Error 0.045
|
-0.68 Percentage of HbA1c
Standard Error 0.042
|
-0.02 Percentage of HbA1c
Standard Error 0.039
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who had IGT at baseline, received at least one dose of study drug, and had evaluable data for this outcome.
Change from Baseline in Fasting Insulin for Participants with IGT at Baseline. LS mean was determined using MMRM model log(Baseline) + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=34 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=37 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=46 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Fasting Insulin for Participants With IGT at Baseline
|
-6.04 milli-international units/liter (mIU/L)
Standard Error 0.517
|
-6.69 milli-international units/liter (mIU/L)
Standard Error 0.433
|
-2.13 milli-international units/liter (mIU/L)
Standard Error 0.776
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Change from Baseline in Systolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=59 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=65 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=66 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure
|
-11.2 millimeters of Mercury (mmHg)
Standard Error 1.42
|
-12.0 millimeters of Mercury (mmHg)
Standard Error 1.35
|
1.9 millimeters of Mercury (mmHg)
Standard Error 1.35
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
Change from Baseline in Diastolic Blood Pressure. LS mean was determined using MMRM model with Baseline + Hyperlipidemia at Screening + NAFLD at Screening + IGT at Screening + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=59 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=65 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=66 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure
|
-5.9 millimeters of Mercury (mmHg)
Standard Error 1.09
|
-6.3 millimeters of Mercury (mmHg)
Standard Error 1.04
|
0.5 millimeters of Mercury (mmHg)
Standard Error 1.04
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Information from these 8 domains is further aggregated into 2 health component summary scores: Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths. Scoring of each domain and both summary scores are norm based and presented in the form of T scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=63 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=68 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=69 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score
|
1.1 Score on a scale
Standard Error 0.39
|
2.0 Score on a scale
Standard Error 0.37
|
-0.1 Score on a scale
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related HRQoL: Physical (7 items) and Psychosocial (13 items). A 5-item subset of the Physical domain - the Physical Function composite - is also supported. Items in the Physical Function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=63 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=69 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=69 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
|
15.2 Score on a scale
Standard Error 2.05
|
13.0 Score on a scale
Standard Error 1.95
|
2.2 Score on a scale
Standard Error 1.96
|
SECONDARY outcome
Timeframe: Baseline, Week 72Population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug and had evaluable data for this outcome.
The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, unable to perform/extreme problems). In addition to the health profile, a single health state index value can be derived based on a formula that attaches weights to each of the levels in each dimension. This index value ranges between ˂0 (where 0 is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). LS mean was determined using ANCOVA model with Week 0 (Visit 3) + IGT at Screening + Hyperlipidemia at Screening + NAFLD at Screening + Sex + Treatment (Type III sum of squares) as variables.
Outcome measures
| Measure |
10 mg Tirzepatide
n=63 Participants
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered SC QW.
|
15 mg Tirzepatide
n=68 Participants
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=69 Participants
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)
|
0.01 Score on a scale
Standard Error 0.011
|
0.01 Score on a scale
Standard Error 0.011
|
-0.01 Score on a scale
Standard Error 0.011
|
Adverse Events
10 mg Tirzepatide
Serious events: 8 serious events
Other events: 59 other events
Deaths: 0 deaths
15 mg Tirzepatide
Serious events: 5 serious events
Other events: 65 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10 mg Tirzepatide
n=73 participants at risk
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide SC QW
.
|
15 mg Tirzepatide
n=77 participants at risk
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=75 participants at risk
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Covid-19
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Pneumonia bacterial
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.3%
1/43 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/45 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/45 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Brain stem infarction
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Cerebral infarction
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/43 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/45 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.2%
1/45 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
Other adverse events
| Measure |
10 mg Tirzepatide
n=73 participants at risk
Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide SC QW
.
|
15 mg Tirzepatide
n=77 participants at risk
Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
|
Placebo
n=75 participants at risk
Participants received matching placebo administered SC QW.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Cardiac disorders
Extrasystoles
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Cardiac disorders
Paroxysmal arrhythmia
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Ear and labyrinth disorders
Conductive deafness
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Ear and labyrinth disorders
Vertigo positional
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.7%
2/75 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Eye disorders
Cataract
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Eye disorders
Conjunctival haemorrhage
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Eye disorders
Glaucoma
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.8%
5/73 • Number of events 11 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
5.2%
4/77 • Number of events 6 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
2/73 • Number of events 5 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.1%
3/73 • Number of events 4 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.9%
3/77 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.7%
2/75 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Constipation
|
16.4%
12/73 • Number of events 14 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
27.3%
21/77 • Number of events 23 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
6.7%
5/75 • Number of events 16 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Dental caries
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
4.0%
3/75 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.3%
9/73 • Number of events 15 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
9.1%
7/77 • Number of events 8 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
4.0%
3/75 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.7%
2/75 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
2/73 • Number of events 6 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.9%
3/77 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.4%
1/73 • Number of events 31 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Eructation
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Gastric polyps
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Gingival pain
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.7%
2/75 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Nausea
|
13.7%
10/73 • Number of events 13 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
23.4%
18/77 • Number of events 40 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
4.0%
3/75 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Stomatitis
|
2.7%
2/73 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
5/73 • Number of events 11 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
11.7%
9/77 • Number of events 11 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
4.0%
3/75 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Chest pain
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Generalised oedema
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Injection site erythema
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 8 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Injection site haematoma
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Injection site oedema
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Injection site pruritus
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Injection site reaction
|
5.5%
4/73 • Number of events 43 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
5.2%
4/77 • Number of events 28 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Injection site urticaria
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Malaise
|
2.7%
2/73 • Number of events 5 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.9%
3/77 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Pyrexia
|
13.7%
10/73 • Number of events 10 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
14.3%
11/77 • Number of events 15 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
14.7%
11/75 • Number of events 14 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Vaccination site swelling
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
General disorders
Vaccination site warmth
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Immune system disorders
Seasonal allergy
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.7%
2/75 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Bartholin's abscess
|
3.3%
1/30 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Conjunctivitis viral
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Covid-19
|
20.5%
15/73 • Number of events 15 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
19.5%
15/77 • Number of events 15 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
17.3%
13/75 • Number of events 14 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Cystitis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.9%
3/77 • Number of events 5 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Folliculitis genital
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Gastroenteritis
|
2.7%
2/73 • Number of events 4 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Helicobacter infection
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Herpes zoster
|
4.1%
3/73 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Hordeolum
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Infected bite
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Influenza
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
7/73 • Number of events 11 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
10.7%
8/75 • Number of events 9 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Otitis externa
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Otitis media
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Paronychia
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Tinea manuum
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.7%
2/75 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Tonsillitis
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Tooth abscess
|
2.7%
2/73 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Infections and infestations
Varicella
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Injury, poisoning and procedural complications
Chillblains
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
4.0%
3/75 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
1.4%
1/73 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
5.2%
4/77 • Number of events 4 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
5.3%
4/75 • Number of events 4 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Injury, poisoning and procedural complications
Post vaccination fever
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Albumin urine present
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
4.0%
3/75 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Amylase increased
|
4.1%
3/73 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Blood calcitonin increased
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.7%
2/73 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Blood pressure decreased
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Haemoglobin decreased
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Helicobacter test positive
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Lipase increased
|
2.7%
2/73 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Pancreatic enzymes increased
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Prostatic specific antigen increased
|
2.3%
1/43 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/45 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/45 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Protein urine present
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Investigations
White blood cell count decreased
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.3%
9/73 • Number of events 9 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
7.8%
6/77 • Number of events 7 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Metabolism and nutrition disorders
Gout
|
2.7%
2/73 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
4.0%
3/75 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
5.2%
4/77 • Number of events 5 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
4/73 • Number of events 5 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.9%
3/77 • Number of events 3 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
5.3%
4/75 • Number of events 6 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.7%
2/75 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.7%
2/75 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal submucosal tumour
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sweat gland tumour
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Dizziness
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.9%
3/77 • Number of events 4 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Dysaesthesia
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Headache
|
2.7%
2/73 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
6.7%
5/75 • Number of events 6 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Hypoaesthesia
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Migraine
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Paraesthesia
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Syncope
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Taste disorder
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Psychiatric disorders
Adjustment disorder
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Psychiatric disorders
Insomnia
|
2.7%
2/73 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Renal and urinary disorders
Renal cyst
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Renal and urinary disorders
Ureterolithiasis
|
1.4%
1/73 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Renal and urinary disorders
Urinary retention
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/32 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.3%
1/30 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.1%
1/32 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/30 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Reproductive system and breast disorders
Prostatitis
|
2.3%
1/43 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/45 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/45 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.7%
2/73 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.6%
2/77 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord atrophy
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord inflammation
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
3.9%
3/77 • Number of events 5 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Surgical and medical procedures
Mass excision
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/43 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/45 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
2.2%
1/45 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Vascular disorders
Artery dissection
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Vascular disorders
Hypertension
|
0.00%
0/73 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/75 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Vascular disorders
Hypotension
|
2.7%
2/73 • Number of events 2 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/77 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
|
Vascular disorders
Orthostatic hypotension
|
1.4%
1/73 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
1.3%
1/77 • Number of events 1 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
0.00%
0/75 • Baseline Through Safety Follow-Up (Up To 76 Weeks)
All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60