Trial Outcomes & Findings for A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes (NCT NCT03861039)
NCT ID: NCT03861039
Last Updated: 2022-02-14
Results Overview
An SAE is any AE from this study that results in one of the following outcomes: * Death * Initial or prolonged inpatient hospitalization * A life-threatening experience (that is, immediate risk of dying) * Persistent or significant disability/incapacity * Congenital anomaly/birth defect. * Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
443 participants
Primary outcome timeframe
Baseline through Week 52
Results posted on
2022-02-14
Participant Flow
Participant milestones
| Measure |
5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Overall Study
STARTED
|
148
|
147
|
148
|
|
Overall Study
Received at Least One Dose of Study Drug
|
148
|
147
|
148
|
|
Overall Study
COMPLETED
|
145
|
139
|
133
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
15
|
Reasons for withdrawal
| Measure |
5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
5
|
11
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
4
|
Baseline Characteristics
A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
5 mg Tirzepatide
n=148 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=147 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=148 Participants
15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
Total
n=443 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Hemoglobin A1c
|
8.53 : Percentage of HbA1c
STANDARD_DEVIATION 1.15 • n=5 Participants
|
8.56 : Percentage of HbA1c
STANDARD_DEVIATION 1.05 • n=7 Participants
|
8.59 : Percentage of HbA1c
STANDARD_DEVIATION 1.09 • n=5 Participants
|
8.56 : Percentage of HbA1c
STANDARD_DEVIATION 1.09 • n=4 Participants
|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
336 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
148 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
443 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
148 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
443 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
148 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
443 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 52Population: All randomized participants who received at least one dose of study drug.
An SAE is any AE from this study that results in one of the following outcomes: * Death * Initial or prolonged inpatient hospitalization * A life-threatening experience (that is, immediate risk of dying) * Persistent or significant disability/incapacity * Congenital anomaly/birth defect. * Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
5 mg Tirzepatide
n=148 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=147 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=148 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
5 mg Tirzepatide
n=148 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=146 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=145 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
|
-2.57 Percentage of HbA1c
Standard Error 0.075
|
-2.98 Percentage of HbA1c
Standard Error 0.075
|
-3.02 Percentage of HbA1c
Standard Error 0.077
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
5 mg Tirzepatide
n=148 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=146 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=145 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve HbA1c <7%
|
92.57 percentage of participants
|
97.95 percentage of participants
|
96.55 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
5 mg Tirzepatide
n=148 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=146 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=145 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Change From Baseline in Fasting Serum Glucose
|
-58.6 milligram per Deciliter (mg/dL)
Standard Error 1.75
|
-71.2 milligram per Deciliter (mg/dL)
Standard Error 1.75
|
-74.4 milligram per Deciliter (mg/dL)
Standard Error 1.81
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + OAM Group 1 + Treatment (Type III sum of squares).
Outcome measures
| Measure |
5 mg Tirzepatide
n=136 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=135 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=125 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
|
-80.0 mg/dL
Standard Error 1.91
|
-94.1 mg/dL
Standard Error 1.92
|
-96.3 mg/dL
Standard Error 1.99
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
5 mg Tirzepatide
n=148 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=146 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=145 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Change From Baseline in Body Weight
|
-3.8 Kilograms (kg)
Standard Error 0.51
|
-7.5 Kilograms (kg)
Standard Error 0.51
|
-10.2 Kilograms (kg)
Standard Error 0.52
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline
Outcome measures
| Measure |
5 mg Tirzepatide
n=148 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=146 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=145 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline
|
43.92 percentage of participants
|
70.55 percentage of participants
|
84.14 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
5 mg Tirzepatide
n=143 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=144 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=134 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Change From Baseline in Fasting Insulin
|
6.2 picomol per liter (pmol/L)
Standard Error 2.68
|
-4.8 picomol per liter (pmol/L)
Standard Error 2.21
|
-7.7 picomol per liter (pmol/L)
Standard Error 2.16
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
5 mg Tirzepatide
n=143 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=144 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=134 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Change From Baseline in Fasting C-Peptide
|
-0.12 micrograms/litre (ug/L)
Standard Error 0.044
|
-0.28 micrograms/litre (ug/L)
Standard Error 0.040
|
-0.34 micrograms/litre (ug/L)
Standard Error 0.040
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
5 mg Tirzepatide
n=139 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=135 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=128 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin)
|
39.7 percentage of HOMA-2B
Standard Error 2.16
|
44.9 percentage of HOMA-2B
Standard Error 2.40
|
49.2 percentage of HOMA-2B
Standard Error 2.60
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
5 mg Tirzepatide
n=139 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=135 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=128 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Change From Baseline in HOMA-2S (Insulin)
|
-0.1 Percentage of HOMA-2S
Standard Error 3.37
|
16.7 Percentage of HOMA-2S
Standard Error 4.23
|
24.1 Percentage of HOMA-2S
Standard Error 4.66
|
SECONDARY outcome
Timeframe: Baseline through Week 56Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
The hypoglycemia events were defined by participant reported events with blood glucose \<54mg/dL (\<3.0 mmol/L) or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Outcome measures
| Measure |
5 mg Tirzepatide
n=148 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=147 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=148 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: All randomized participants who received at least one dose of study drug.
Number of Participants with Anti-Tirzepatide Antibodies
Outcome measures
| Measure |
5 mg Tirzepatide
n=148 Participants
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=147 Participants
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=148 Participants
15 mg tirzepatide administered SC once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Number of Participants With Anti-Tirzepatide Antibodies
|
87 Participants
|
82 Participants
|
88 Participants
|
Adverse Events
5 mg Tirzepatide
Serious events: 2 serious events
Other events: 109 other events
Deaths: 0 deaths
10 mg Tirzepatide
Serious events: 11 serious events
Other events: 108 other events
Deaths: 0 deaths
15 mg Tirzepatide
Serious events: 11 serious events
Other events: 124 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg Tirzepatide
n=148 participants at risk
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=147 participants at risk
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=148 participants at risk
15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia legionella
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Intra-cerebral aneurysm operation
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
5 mg Tirzepatide
n=148 participants at risk
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
10 mg Tirzepatide
n=147 participants at risk
10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
15 mg Tirzepatide
n=148 participants at risk
15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastric disorder
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/147 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Blepharitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Corneal leukoma
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/147 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Dry eye
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Glaucoma
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Iridocyclitis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Maculopathy
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Ocular hypertension
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.1%
9/148 • Number of events 10 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
7/147 • Number of events 9 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
8/148 • Number of events 10 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
5/148 • Number of events 6 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.1%
6/147 • Number of events 7 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.1%
6/148 • Number of events 7 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
2/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/147 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
5/148 • Number of events 5 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anal fissure
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
8.1%
12/148 • Number of events 12 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.6%
20/147 • Number of events 21 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.9%
22/148 • Number of events 24 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
2.0%
3/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
11/148 • Number of events 24 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.6%
20/147 • Number of events 40 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.5%
20/148 • Number of events 28 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.1%
6/148 • Number of events 6 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.5%
11/147 • Number of events 19 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
5/148 • Number of events 6 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Faeces soft
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.7%
4/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.1%
6/147 • Number of events 6 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
9.5%
14/148 • Number of events 60 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.6%
20/147 • Number of events 35 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
27.0%
40/148 • Number of events 51 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
4/148 • Number of events 5 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.5%
11/147 • Number of events 13 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.1%
15/148 • Number of events 23 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.68%
1/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site haemorrhage
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
2.7%
4/148 • Number of events 7 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/147 • Number of events 25 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/148 • Number of events 72 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Malaise
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/147 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.1%
6/148 • Number of events 6 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Fatty liver alcoholic
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Adenoviral conjunctivitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/147 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 6 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Dermatitis infected
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Empyema
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Furuncle
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
4.7%
7/148 • Number of events 9 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
5/147 • Number of events 5 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gingivitis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Helicobacter infection
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Hepatitis e
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/147 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Hordeolum
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
3.4%
5/148 • Number of events 5 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasal vestibulitis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
18.9%
28/148 • Number of events 34 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
13.6%
20/147 • Number of events 26 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
18.2%
27/148 • Number of events 37 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Otitis media
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Paronychia
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Parotitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Periodontitis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/147 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Rhinitis
|
2.0%
3/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Varicella
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/29 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.9%
2/34 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/44 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/147 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.4%
2/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/147 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Amylase increased
|
1.4%
2/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/147 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood calcitonin increased
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood pressure decreased
|
1.4%
2/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram st segment depression
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Heart rate increased
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Helicobacter test positive
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Lipase increased
|
2.7%
4/148 • Number of events 5 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/147 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.1%
9/148 • Number of events 9 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Occult blood
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Occult blood positive
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Salmonella test positive
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
8/147 • Number of events 8 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.1%
6/148 • Number of events 6 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.4%
11/148 • Number of events 11 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.2%
15/147 • Number of events 18 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.2%
18/148 • Number of events 19 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.68%
1/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcitoninaemia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.68%
1/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
4/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
8/147 • Number of events 8 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/29 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/34 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.3%
1/44 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
8/148 • Number of events 8 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/147 • Number of events 6 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
2.7%
4/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/147 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
3/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Panic disorder
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Calculus urinary
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrocalcinosis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal cyst
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal impairment
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/119 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.88%
1/113 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/104 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/29 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.00%
0/29 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/44 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cystic lung disease
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.7%
4/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.7%
4/148 • Number of events 4 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
3/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.4%
2/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Skin lesion removal
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Transurethral bladder resection
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Ureteric calculus removal
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Urethral stent insertion
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Arteriosclerosis
|
1.4%
2/148 • Number of events 2 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/148 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
2.0%
3/148 • Number of events 3 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/147 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Orthostatic hypotension
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/147 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.68%
1/148 • Number of events 1 • Baseline through Week 56
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60