Trial Outcomes & Findings for A Study of LY3337641 in Rheumatoid Arthritis (NCT NCT02628028)
NCT ID: NCT02628028
Last Updated: 2019-10-09
Results Overview
TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. Skin Rash was the only event that was considered an AESI. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
286 participants
Primary outcome timeframe
Up to 6 Weeks
Results posted on
2019-10-09
Participant Flow
The study consist of 2-parts. Part A included participants with at least mildly active rheumatoid arthritis (RA) and Part B included participants with moderately to severely active RA. Long-term extension (LTE) period allowed eligible participants who completed Part B of study to receive LY3337641 up to an additional 52 weeks.
Participant milestones
| Measure |
Part A: Placebo
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
Part B: Placebo
Participants received oral dose of placebo QD for 12 weeks.
|
Part B: 5 mg LY3337641
Part B Dosing period: Participants received oral dose of 5 mg LY3337641 tablet QD for 12 weeks.
Long-term extension (LTE) period: Participants who completed Part B of study received oral dose of 5 mg LY3337641 QD for an additional 52 weeks.
|
Part B: 10 mg LY3337641
Participants received oral dose of 10 mg LY3337641 tablet QD for 12 weeks.
Long-term extension (LTE) period: Participants who completed Part B of study received oral dose of 10 mg LY3337641 QD for an additional 52 weeks.
|
Part B: 30 mg LY3337641
Participants received oral dose of 30 mg LY3337641 QD for 12 weeks.
Long-term extension (LTE) period: Participants who completed Part B of study received oral dose of 30 mg LY3337641 QD for an additional 52 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Dosing Period
COMPLETED
|
9
|
9
|
9
|
8
|
46
|
49
|
46
|
48
|
|
Dosing Period
NOT COMPLETED
|
0
|
0
|
1
|
0
|
16
|
14
|
16
|
15
|
|
Dosing Period
Received at Least 1dose of Study Drug
|
9
|
9
|
10
|
8
|
62
|
63
|
62
|
63
|
|
Dosing Period
STARTED
|
9
|
9
|
10
|
8
|
62
|
63
|
62
|
63
|
|
Long-term Extension (LTE) Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
61
|
58
|
61
|
|
Long-term Extension (LTE) Period
Placebo Re-randomized in LTE
|
0
|
0
|
0
|
0
|
0
|
14
|
14
|
14
|
|
Long-term Extension (LTE) Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Long-term Extension (LTE) Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
60
|
58
|
61
|
Reasons for withdrawal
| Measure |
Part A: Placebo
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
Part B: Placebo
Participants received oral dose of placebo QD for 12 weeks.
|
Part B: 5 mg LY3337641
Part B Dosing period: Participants received oral dose of 5 mg LY3337641 tablet QD for 12 weeks.
Long-term extension (LTE) period: Participants who completed Part B of study received oral dose of 5 mg LY3337641 QD for an additional 52 weeks.
|
Part B: 10 mg LY3337641
Participants received oral dose of 10 mg LY3337641 tablet QD for 12 weeks.
Long-term extension (LTE) period: Participants who completed Part B of study received oral dose of 10 mg LY3337641 QD for an additional 52 weeks.
|
Part B: 30 mg LY3337641
Participants received oral dose of 30 mg LY3337641 QD for 12 weeks.
Long-term extension (LTE) period: Participants who completed Part B of study received oral dose of 30 mg LY3337641 QD for an additional 52 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Dosing Period
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
2
|
4
|
1
|
1
|
|
Dosing Period
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
1
|
3
|
2
|
|
Dosing Period
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dosing Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
3
|
0
|
1
|
0
|
|
Dosing Period
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
7
|
6
|
7
|
7
|
|
Dosing Period
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dosing Period
Site Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Dosing Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Dosing Period
Other
|
0
|
0
|
0
|
0
|
2
|
1
|
2
|
4
|
|
Long-term Extension (LTE) Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
3
|
|
Long-term Extension (LTE) Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Long-term Extension (LTE) Period
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
52
|
51
|
51
|
|
Long-term Extension (LTE) Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
3
|
|
Long-term Extension (LTE) Period
Other
|
0
|
0
|
0
|
0
|
0
|
3
|
4
|
3
|
Baseline Characteristics
A Study of LY3337641 in Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Part A: Placebo
n=9 Participants
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
n=9 Participants
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
n=10 Participants
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
n=8 Participants
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
Part B: Placebo
n=62 Participants
Participants received oral dose of placebo QD for 12 weeks.
|
Part B: 5 mg LY3337641
n=63 Participants
Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
|
Part B: 10 mg LY3337641
n=62 Participants
Participants received oral dose of 10 mg LY3337641 QD for 12 weeks.
|
Part B: 30 mg LY3337641
n=63 Participants
Participants received oral dose of 30 mg LY3337641 QD for 12 weeks.
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 11.75 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 6.44 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 5.72 • n=4 Participants
|
50.5 years
STANDARD_DEVIATION 8.75 • n=21 Participants
|
50.1 years
STANDARD_DEVIATION 9.20 • n=8 Participants
|
51.7 years
STANDARD_DEVIATION 9.36 • n=8 Participants
|
51.9 years
STANDARD_DEVIATION 8.91 • n=24 Participants
|
51.5 years
STANDARD_DEVIATION 9.09 • n=42 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
53 Participants
n=8 Participants
|
56 Participants
n=8 Participants
|
53 Participants
n=24 Participants
|
246 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
40 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
21 Participants
n=24 Participants
|
116 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
126 Participants
n=42 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
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
44 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
40 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
51 Participants
n=24 Participants
|
229 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
|
Region of Enrollment
Argentina
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
57 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
71 Participants
n=42 Participants
|
|
Region of Enrollment
Japan
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Region of Enrollment
South Korea
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Region of Enrollment
Austria
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
Poland
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Region of Enrollment
Mexico
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
|
Region of Enrollment
South Africa
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Region of Enrollment
Slovakia
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Region of Enrollment
Australia
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 6 WeeksPopulation: All randomized participants who received at least 1 dose of the study drug in Part A.
TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. Skin Rash was the only event that was considered an AESI. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
n=9 Participants
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
n=10 Participants
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
n=8 Participants
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
|---|---|---|---|---|
|
Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs) or Adverse Events of Special Interest (AESIs) or Any Serious AEs (SAEs) in Part A
AESIs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs) or Adverse Events of Special Interest (AESIs) or Any Serious AEs (SAEs) in Part A
TEAEs
|
3 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs) or Adverse Events of Special Interest (AESIs) or Any Serious AEs (SAEs) in Part A
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient's Global Assessment of Arthritis Pain using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI) and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and /or participants who discontinue study or drug before analysis timepoint are deemed non-responders.
Outcome measures
| Measure |
Part A: Placebo
n=54 Participants
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
n=56 Participants
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
n=52 Participants
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
n=55 Participants
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response in Part B
|
48.1 Percentage of Participants
Interval 34.8 to 61.5
|
55.4 Percentage of Participants
Interval 42.3 to 68.4
|
44.2 Percentage of Participants
Interval 30.7 to 57.7
|
50.9 Percentage of Participants
Interval 37.7 to 64.1
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).
ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient's Global Assessment of Arthritis Pain using VAS, HAQ-DI and hsCRP. Participants with missing responses and/or participants who discontinue study or drug before analysis timepoint are deemed non-responders.
Outcome measures
| Measure |
Part A: Placebo
n=54 Participants
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
n=56 Participants
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
n=52 Participants
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
n=55 Participants
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response in Part B
|
27.8 Percentage of Participants
Interval 15.8 to 39.7
|
25.0 Percentage of Participants
Interval 13.7 to 36.3
|
15.4 Percentage of Participants
Interval 5.6 to 25.2
|
29.1 Percentage of Participants
Interval 17.1 to 41.1
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).
ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR70 Responder" is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient's Global Assessment of Arthritis Pain using VAS, HAQ-DI and hsCRP. Participants with missing responses and/or participants who discontinue study or drug before analysis timepoint are deemed non-responders.
Outcome measures
| Measure |
Part A: Placebo
n=54 Participants
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
n=56 Participants
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
n=52 Participants
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
n=55 Participants
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response in Part B
|
16.7 Percentage of Participants
Interval 6.7 to 26.6
|
8.9 Percentage of Participants
Interval 1.5 to 16.4
|
1.9 Percentage of Participants
Interval 0.0 to 5.7
|
16.4 Percentage of Participants
Interval 6.6 to 26.1
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using VAS. DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Outcome measures
| Measure |
Part A: Placebo
n=62 Participants
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
n=63 Participants
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
n=62 Participants
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
n=63 Participants
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in the Disease Activity Score (DAS) 28-high-sensitivity C-reactive Protein (hsCRP) in Part B
|
-1.62 units on a scale
Standard Deviation 1.447
|
-1.55 units on a scale
Standard Deviation 1.182
|
-1.24 units on a scale
Standard Deviation 1.146
|
-1.80 units on a scale
Standard Deviation 1.453
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using VAS. DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Outcome measures
| Measure |
Part A: Placebo
n=54 Participants
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
n=56 Participants
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
n=52 Participants
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
n=55 Participants
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieve Low Disease Activity Using DAS28-hsCRP in Part B
|
27.8 Percentage of Participants
Interval 15.8 to 39.7
|
32.1 Percentage of Participants
Interval 19.9 to 44.4
|
21.2 Percentage of Participants
Interval 10.1 to 32.3
|
29.1 Percentage of Participants
Interval 17.1 to 41.1
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*Patient's Global VAS+0.96. Clinical remission is defined as DAS28-hsCRP \<2.6.
Outcome measures
| Measure |
Part A: Placebo
n=54 Participants
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
n=56 Participants
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
n=52 Participants
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
n=55 Participants
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieve Clinical Remission Using DAS28-hsCRP in Part B
|
20.4 Percentage of Participants
Interval 9.6 to 31.1
|
19.6 Percentage of Participants
Interval 9.2 to 30.0
|
7.7 Percentage of Participants
Interval 0.4 to 14.9
|
25.5 Percentage of Participants
Interval 13.9 to 37.0
|
SECONDARY outcome
Timeframe: Part A: Weeks 1, 2, and 4, Day 1 (0.5 to 2 hours postdose); Part B: Weeks 2, 4, 8, and 12, Day 1 (0.5 to 2 hours postdose)Population: All randomized participants who received at least 1 dose of the study drug and have evaluable PK data in in Part A and Part B.
Apparent total body clearance of drug after oral administration based on population PK analysis was evaluated. As prespecified per protocol, an overall population estimate of clearance is generated and data from Part A and B were combined for the analysis. The sparse data was then analyzed using population PK methods in Non linear Mixed Effects Model (NONMEM) to generate an overall population estimate of clearance.
Outcome measures
| Measure |
Part A: Placebo
n=209 Participants
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Clearance Parameter of LY3337641
|
29.1 Liter per hour (L/hr)
Standard Error 5.9
|
—
|
—
|
—
|
Adverse Events
Part A: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 5 mg LY3337641
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: 10 mg LY3337641
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: 30 mg LY3337641
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: Placebo
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Part B: 5 mg LY3337641
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part B: 10 mg LY3337641
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part B: 30 mg LY3337641
Serious events: 3 serious events
Other events: 19 other events
Deaths: 1 deaths
Long-Term Extension: 5 mg LY3337641
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Long-Term Extension: 10 mg LY3337641
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Long-Term Extension: 30 mg LY3337641
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Placebo
n=9 participants at risk
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
n=9 participants at risk
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
n=10 participants at risk
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
n=8 participants at risk
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
Part B: Placebo
n=62 participants at risk
Participants received oral dose of placebo QD for 12 weeks.
|
Part B: 5 mg LY3337641
n=63 participants at risk
Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
|
Part B: 10 mg LY3337641
n=62 participants at risk
Participants received oral dose of 10 mg LY3337641 QD for 12 weeks.
|
Part B: 30 mg LY3337641
n=63 participants at risk
Participants received oral dose of 30 mg LY3337641 QD for 12 weeks.
|
Long-Term Extension: 5 mg LY3337641
n=61 participants at risk
Participants who completed Part B of study received oral dose of 5 mg LY3337641 QD for an additional 52 weeks.
|
Long-Term Extension: 10 mg LY3337641
n=58 participants at risk
Participants who completed Part B of study received oral dose of 10 mg LY3337641 QD for an additional 52 weeks.
|
Long-Term Extension: 30 mg LY3337641
n=61 participants at risk
Participants who completed Part B of study received oral dose of 30 mg LY3337641 QD for an additional 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/61 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Hand fracture
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Joint dislocation
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Multiple injuries
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Patella fracture
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Pubis fracture
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Wrist fracture
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/61 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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 |
Part A: Placebo
n=9 participants at risk
Participants received oral dose of placebo once daily (QD) for 4 weeks.
|
Part A: 5 mg LY3337641
n=9 participants at risk
Participants received oral dose of 5 mg LY3337641 QD for 4 weeks.
|
Part A: 10 mg LY3337641
n=10 participants at risk
Participants received oral dose of 10 mg LY3337641 QD for 4 weeks.
|
Part A: 30 mg LY3337641
n=8 participants at risk
Participants received oral dose of 30 mg LY3337641 QD for 4 weeks.
|
Part B: Placebo
n=62 participants at risk
Participants received oral dose of placebo QD for 12 weeks.
|
Part B: 5 mg LY3337641
n=63 participants at risk
Participants received oral dose of 5 mg LY3337641 QD for 12 weeks.
|
Part B: 10 mg LY3337641
n=62 participants at risk
Participants received oral dose of 10 mg LY3337641 QD for 12 weeks.
|
Part B: 30 mg LY3337641
n=63 participants at risk
Participants received oral dose of 30 mg LY3337641 QD for 12 weeks.
|
Long-Term Extension: 5 mg LY3337641
n=61 participants at risk
Participants who completed Part B of study received oral dose of 5 mg LY3337641 QD for an additional 52 weeks.
|
Long-Term Extension: 10 mg LY3337641
n=58 participants at risk
Participants who completed Part B of study received oral dose of 10 mg LY3337641 QD for an additional 52 weeks.
|
Long-Term Extension: 30 mg LY3337641
n=61 participants at risk
Participants who completed Part B of study received oral dose of 30 mg LY3337641 QD for an additional 52 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
11.1%
1/9 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/63 • Number of events 3 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/61 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.3%
4/63 • Number of events 4 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/63 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/61 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.2%
3/58 • Number of events 4 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/61 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Laryngitis
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/61 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
3/63 • Number of events 3 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.9%
5/63 • Number of events 5 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/61 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/61 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
11.1%
1/9 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/62 • Number of events 3 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
3/63 • Number of events 4 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/61 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
11.1%
1/9 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/61 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Urinary tract infection
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/61 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.2%
3/58 • Number of events 4 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.6%
4/61 • Number of events 4 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Hypertriglyceridaemia
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/61 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Hypokalaemia
|
11.1%
1/9 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/63 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Osteopenia
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.1%
1/9 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Rheumatoid arthritis
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
3/63 • Number of events 4 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.5%
4/62 • Number of events 4 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
2/63 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/61 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/61 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Carotid artery aneurysm
|
11.1%
1/9 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
11.1%
1/9 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/61 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
20.0%
2/10 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/62 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/58 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/61 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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%
0/1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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
Erectile dysfunction
|
0.00%
0/1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/3 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/6 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/4 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/10 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/9 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/8 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/63 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/61 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.3%
2/61 • Number of events 2 • Up to 88 Weeks
All randomized participants who received at least 1 dose of the 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: GT60