Trial Outcomes & Findings for A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain (NCT NCT02192190)
NCT ID: NCT02192190
Last Updated: 2019-09-10
Results Overview
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis (OA) symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC pain subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 millimeter \[mm\] VAS; 0=very good and 100=very poor) of all 5 questions related to pain. Bayesian posterior adjusted mean was calculated using a Bayesian Normal Dynamic Linear Model (NDLM) dose response model with baseline and pooled investigator site included as baseline covariates.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
268 participants
Primary outcome timeframe
Baseline, 8 Weeks
Results posted on
2019-09-10
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
|
Celecoxib
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
|
LY2951742 5 mg + Placebo
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 50 mg + Placebo
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 120 mg + Placebo
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 300 mg + Placebo
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
76
|
39
|
38
|
38
|
39
|
38
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
76
|
39
|
38
|
38
|
38
|
37
|
|
Overall Study
COMPLETED
|
22
|
10
|
13
|
12
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
54
|
29
|
25
|
26
|
30
|
29
|
Reasons for withdrawal
| Measure |
Placebo
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
|
Celecoxib
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
|
LY2951742 5 mg + Placebo
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 50 mg + Placebo
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 120 mg + Placebo
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 300 mg + Placebo
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
2
|
1
|
4
|
3
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Terminated by Sponsor
|
43
|
23
|
20
|
23
|
21
|
23
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
2
|
1
|
5
|
3
|
|
Overall Study
Could not Keep Visit Schedule
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Positive Drug Screen
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Inadequate Pain Relief
|
0
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=76 Participants
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
|
Celecoxib
n=39 Participants
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
|
LY2951742 5 mg + Placebo
n=38 Participants
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 50 mg + Placebo
n=38 Participants
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 120 mg + Placebo
n=38 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 300 mg + Placebo
n=37 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 7.94 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 9.86 • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 7.95 • n=4 Participants
|
58 years
STANDARD_DEVIATION 9.29 • n=21 Participants
|
56.4 years
STANDARD_DEVIATION 9.38 • n=10 Participants
|
58.2 years
STANDARD_DEVIATION 8.91 • n=115 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
164 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
102 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
135 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
130 Participants
n=115 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
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
75 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
181 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 WeeksPopulation: Full Analysis Set (FAS) is the number of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8. The 95% Crl (Credible Interval) is reported, not confidence interval (CI).
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis (OA) symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC pain subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 millimeter \[mm\] VAS; 0=very good and 100=very poor) of all 5 questions related to pain. Bayesian posterior adjusted mean was calculated using a Bayesian Normal Dynamic Linear Model (NDLM) dose response model with baseline and pooled investigator site included as baseline covariates.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
|
Celecoxib
n=32 Participants
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
|
LY2951742 5 mg + Placebo
n=31 Participants
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 50 mg + Placebo
n=31 Participants
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 120 mg + Placebo
n=30 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 300 mg + Placebo
n=30 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
|
-19.2 mm
Interval -24.7 to -13.4
|
-31.3 mm
Interval -40.1 to -22.5
|
-16.4 mm
Interval -23.9 to -8.6
|
-24.2 mm
Interval -31.0 to -17.2
|
-21.8 mm
Interval -29.3 to -14.2
|
-17.7 mm
Interval -25.2 to -10.0
|
SECONDARY outcome
Timeframe: Baseline, 8 WeeksPopulation: FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC physical function subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of all 17 questions related to physical function. Least Square Mean (LSM) was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
|
Celecoxib
n=32 Participants
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
|
LY2951742 5 mg + Placebo
n=31 Participants
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 50 mg + Placebo
n=31 Participants
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 120 mg + Placebo
n=30 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 300 mg + Placebo
n=30 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale
|
-16.5 mm
Interval -22.3 to -10.8
|
-30.6 mm
Interval -38.8 to -22.4
|
-15.4 mm
Interval -23.7 to -7.12
|
-23.5 mm
Interval -31.4 to -15.6
|
-19.5 mm
Interval -28.2 to -10.9
|
-18.4 mm
Interval -26.8 to -9.9
|
SECONDARY outcome
Timeframe: Baseline, 8 WeeksPopulation: FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable PGA assessment at weeks 2, 4, 6 or 8.
The PGA is a patient-rated instrument that measures their assessment of overall OA symptoms. It is based on the participant's response to the question "Considering all the ways your osteoarthritis affects you, how are you doing today?" using a 100 mm VAS (0=very good and 100=very poor). LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Outcome measures
| Measure |
Placebo
n=62 Participants
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
|
Celecoxib
n=31 Participants
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
|
LY2951742 5 mg + Placebo
n=29 Participants
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 50 mg + Placebo
n=30 Participants
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 120 mg + Placebo
n=28 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 300 mg + Placebo
n=28 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis
|
-22.5 mm
Interval -28.8 to -16.2
|
-36.7 mm
Interval -45.7 to -27.6
|
-18.5 mm
Interval -27.9 to -9.1
|
-19.4 mm
Interval -28.0 to -10.8
|
-21.2 mm
Interval -31.2 to -11.1
|
-20.4 mm
Interval -30.0 to -10.9
|
SECONDARY outcome
Timeframe: 8 WeeksPopulation: FAS: Randomized participants who received at least 1 dose of study drug and had at least one post-dose efficacy assessment. N= participants analyzed in the full analysis set with an evaluable response rate at week 8.
The responders according to OMERACT-OARSI criteria: participants with at least 50 % improvement in pain or in function scores, along with absolute improvement of 20 mm, were considered responders. Alternatively, participants were considered responders if they showed at least 20% improvement and absolute improvement of 10 mm in at least two of the following scores: pain, function and Patients Global Assessment (PGA) scores.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
|
Celecoxib
n=20 Participants
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
|
LY2951742 5 mg + Placebo
n=29 Participants
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 50 mg + Placebo
n=22 Participants
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 120 mg + Placebo
n=16 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 300 mg + Placebo
n=19 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI)
|
21 participants
|
14 participants
|
7 participants
|
15 participants
|
10 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline, 8 WeeksPopulation: FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC stiffness subscale will be calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 2 questions related to stiffness. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
|
Celecoxib
n=32 Participants
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
|
LY2951742 5 mg + Placebo
n=31 Participants
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 50 mg + Placebo
n=31 Participants
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 120 mg + Placebo
n=30 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 300 mg + Placebo
n=30 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale
|
-18.5 mm
Interval -24.6 to -12.4
|
-31.4 mm
Interval -40.1 to -22.7
|
-15.1 mm
Interval -24.0 to -6.3
|
-23.7 mm
Interval -32.1 to -15.4
|
-21.3 mm
Interval -30.7 to -12.0
|
-17.3 mm
Interval -26.2 to -8.3
|
SECONDARY outcome
Timeframe: Baseline, 8 WeeksPopulation: FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.
The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales.The WOMAC total score was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 24 questions. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
|
Celecoxib
n=32 Participants
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
|
LY2951742 5 mg + Placebo
n=31 Participants
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 50 mg + Placebo
n=31 Participants
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 120 mg + Placebo
n=30 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 300 mg + Placebo
n=30 Participants
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to 8 Weeks in the WOMAC Total Score
|
-17.0 mm
Interval -22.7 to -11.4
|
-31.1 mm
Interval -39.2 to -23.0
|
-15.6 mm
Interval -23.8 to -7.47
|
-23.7 mm
Interval -31.5 to -15.9
|
-20.0 mm
Interval -28.5 to -11.5
|
-18.4 mm
Interval -26.7 to -10.1
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Celecoxib
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
LY2951742 5 mg + Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LY2951742 50 mg + Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LY2951742 120 mg + Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
LY2951742 300 mg + Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=76 participants at risk
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
|
Celecoxib
n=39 participants at risk
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
|
LY2951742 5 mg + Placebo
n=38 participants at risk
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 50 mg + Placebo
n=38 participants at risk
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 120 mg + Placebo
n=38 participants at risk
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 300 mg + Placebo
n=37 participants at risk
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=76 participants at risk
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
|
Celecoxib
n=39 participants at risk
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
|
LY2951742 5 mg + Placebo
n=38 participants at risk
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 50 mg + Placebo
n=38 participants at risk
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 120 mg + Placebo
n=38 participants at risk
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
|
LY2951742 300 mg + Placebo
n=37 participants at risk
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pharyngitis streptococcal
|
2.6%
2/76 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
5.1%
2/39 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
1.3%
1/76 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Local swelling
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Nodule
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
5.3%
2/38 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Food allergy
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
3.9%
3/76 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
7.9%
3/38 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
4/76 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
5.1%
2/39 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
8.1%
3/37 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Otitis media
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
1/76 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Computerised tomogram abnormal
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram qt prolonged
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
2/76 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.6%
2/76 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
2/76 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
7.7%
3/39 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
5.3%
2/38 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Convulsion
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
2.6%
2/76 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
2.6%
2/76 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
8.1%
3/37 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Seasonal affective disorder
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.7%
1/37 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
2/76 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
1.3%
1/76 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/39 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/76
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/39
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/38
All randomized participants who received at least 1 dose of study drug.
|
2.6%
1/38 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/37
All randomized participants who received at least 1 dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60