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A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02192190
Recruitment Status : Terminated (Interim assessment: Lack of efficacy)
First Posted : July 16, 2014
Results First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis, Knee
Interventions Drug: LY2951742
Other: Placebo- oral
Other: Placebo - SC
Drug: Celecoxib
Enrollment 268
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo
Hide Arm/Group Description Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks. Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
Period Title: Overall Study
Started 76 39 38 38 39 38
Received at Least 1 Dose of Study Drug 76 39 38 38 38 37
Completed 22 10 13 12 9 9
Not Completed 54 29 25 26 30 29
Reason Not Completed
Adverse Event             1             1             0             0             0             0
Lost to Follow-up             3             3             2             1             4             3
Physician Decision             2             0             0             0             0             0
Terminated by Sponsor             43             23             20             23             21             23
Withdrawal by Subject             4             1             2             1             5             3
Could not Keep Visit Schedule             1             0             0             0             0             0
Positive Drug Screen             0             0             0             1             0             0
Inadequate Pain Relief             0             1             1             0             0             0
Arm/Group Title Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo Total
Hide Arm/Group Description Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks. Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks. Total of all reporting groups
Overall Number of Baseline Participants 76 39 38 38 38 37 266
Hide Baseline Analysis Population Description
Randomized participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 39 participants 38 participants 38 participants 38 participants 37 participants 266 participants
58.7  (7.94) 60.8  (9.86) 58.0  (9.60) 56.7  (7.95) 58  (9.29) 56.4  (9.38) 58.2  (8.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 39 participants 38 participants 38 participants 38 participants 37 participants 266 participants
Female
53
  69.7%
24
  61.5%
23
  60.5%
22
  57.9%
23
  60.5%
19
  51.4%
164
  61.7%
Male
23
  30.3%
15
  38.5%
15
  39.5%
16
  42.1%
15
  39.5%
18
  48.6%
102
  38.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 39 participants 38 participants 38 participants 38 participants 37 participants 266 participants
Hispanic or Latino
42
  55.3%
21
  53.8%
17
  44.7%
19
  50.0%
19
  50.0%
17
  45.9%
135
  50.8%
Not Hispanic or Latino
34
  44.7%
18
  46.2%
21
  55.3%
19
  50.0%
18
  47.4%
20
  54.1%
130
  48.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
0
   0.0%
1
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 39 participants 38 participants 38 participants 38 participants 37 participants 266 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.6%
1
   2.6%
2
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
5
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
19
  25.0%
7
  17.9%
11
  28.9%
13
  34.2%
12
  31.6%
13
  35.1%
75
  28.2%
White
54
  71.1%
31
  79.5%
25
  65.8%
25
  65.8%
23
  60.5%
23
  62.2%
181
  68.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.3%
0
   0.0%
0
   0.0%
0
   0.0%
3
   7.9%
1
   2.7%
5
   1.9%
1.Primary Outcome
Title Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
Hide Description 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.
Time Frame Baseline, 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo
Hide Arm/Group Description:
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
Overall Number of Participants Analyzed 65 32 31 31 30 30
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-19.2
(-24.7 to -13.4)
-31.3
(-40.1 to -22.5)
-16.4
(-23.9 to -8.6)
-24.2
(-31.0 to -17.2)
-21.8
(-29.3 to -14.2)
-17.7
(-25.2 to -10.0)
2.Secondary Outcome
Title Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale
Hide Description 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.
Time Frame Baseline, 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo
Hide Arm/Group Description:
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
Overall Number of Participants Analyzed 65 32 31 31 30 30
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-16.5
(-22.3 to -10.8)
-30.6
(-38.8 to -22.4)
-15.4
(-23.7 to -7.12)
-23.5
(-31.4 to -15.6)
-19.5
(-28.2 to -10.9)
-18.4
(-26.8 to -9.9)
3.Secondary Outcome
Title Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis
Hide Description 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.
Time Frame Baseline, 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo
Hide Arm/Group Description:
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
Overall Number of Participants Analyzed 62 31 29 30 28 28
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-22.5
(-28.8 to -16.2)
-36.7
(-45.7 to -27.6)
-18.5
(-27.9 to -9.1)
-19.4
(-28.0 to -10.8)
-21.2
(-31.2 to -11.1)
-20.4
(-30.0 to -10.9)
4.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo
Hide Arm/Group Description:
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
Overall Number of Participants Analyzed 41 20 29 22 16 19
Measure Type: Number
Unit of Measure: participants
21 14 7 15 10 10
5.Secondary Outcome
Title Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale
Hide Description 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.
Time Frame Baseline, 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo
Hide Arm/Group Description:
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
Overall Number of Participants Analyzed 65 32 31 31 30 30
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-18.5
(-24.6 to -12.4)
-31.4
(-40.1 to -22.7)
-15.1
(-24.0 to -6.3)
-23.7
(-32.1 to -15.4)
-21.3
(-30.7 to -12.0)
-17.3
(-26.2 to -8.3)
6.Secondary Outcome
Title Change From Baseline to 8 Weeks in the WOMAC Total Score
Hide Description 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.
Time Frame Baseline, 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo
Hide Arm/Group Description:
Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks.
Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks.
Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
Overall Number of Participants Analyzed 65 32 31 31 30 30
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-17.0
(-22.7 to -11.4)
-31.1
(-39.2 to -23.0)
-15.6
(-23.8 to -7.47)
-23.7
(-31.5 to -15.9)
-20.0
(-28.5 to -11.5)
-18.4
(-26.7 to -10.1)
Time Frame [Not Specified]
Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug.
 
Arm/Group Title Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo
Hide Arm/Group Description Placebo capsule orally, once daily for 16 weeks. Placebo subcutaneous (SC) once every 4 weeks for 16 weeks. Celecoxib 200 milligram (mg) capsule orally once daily for 16 weeks. Placebo SC once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC dose of 5 mg LY2951742 once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC injection of 50 mg LY2951742 once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC injections of 120 mg LY2951742 once every 4 weeks for 16 weeks. Placebo capsule orally, once daily for 16 weeks. SC injections of 300 mg LY2951742 once every 4 weeks for 16 weeks.
All-Cause Mortality
Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/76 (1.32%)      0/39 (0.00%)      0/38 (0.00%)      0/38 (0.00%)      0/38 (0.00%)      1/37 (2.70%)    
Cardiac disorders             
Angina pectoris  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Myocardial infarction  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Gastrointestinal disorders             
Small intestinal obstruction  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Infections and infestations             
Catheter site infection  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Celecoxib LY2951742 5 mg + Placebo LY2951742 50 mg + Placebo LY2951742 120 mg + Placebo LY2951742 300 mg + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/76 (35.53%)      13/39 (33.33%)      8/38 (21.05%)      8/38 (21.05%)      13/38 (34.21%)      9/37 (24.32%)    
Cardiac disorders             
Atrial fibrillation  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Atrioventricular block  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Left ventricular hypertrophy  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Gastrointestinal disorders             
Abdominal discomfort  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Abdominal pain  1  0/76 (0.00%)  0 2/39 (5.13%)  3 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Constipation  1  1/76 (1.32%)  1 1/39 (2.56%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Diarrhoea  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Flatulence  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Food poisoning  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Large intestine polyp  1  0/76 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Nausea  1  0/76 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Toothache  1  1/76 (1.32%)  2 1/39 (2.56%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Vomiting  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
General disorders             
Chest pain  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Fatigue  1  1/76 (1.32%)  1 0/39 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Injection site reaction  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Local swelling  1  0/76 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Nodule  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Oedema peripheral  1  0/76 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Pain  1  1/76 (1.32%)  1 0/39 (0.00%)  0 2/38 (5.26%)  2 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Pyrexia  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Immune system disorders             
Drug hypersensitivity  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Food allergy  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Seasonal allergy  1  0/76 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Infections and infestations             
Bronchitis  1  1/76 (1.32%)  1 1/39 (2.56%)  1 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Ear infection  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Gastroenteritis viral  1  3/76 (3.95%)  3 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Influenza  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 3/38 (7.89%)  3 0/38 (0.00%)  0 0/37 (0.00%)  0
Nasopharyngitis  1  4/76 (5.26%)  4 2/39 (5.13%)  2 0/38 (0.00%)  0 1/38 (2.63%)  1 1/38 (2.63%)  1 3/37 (8.11%)  3
Oral herpes  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Otitis externa  1  0/76 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Otitis media  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Pharyngitis streptococcal  1  2/76 (2.63%)  2 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Tonsillitis  1  0/76 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Tooth infection  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Upper respiratory tract infection  1  1/76 (1.32%)  2 1/39 (2.56%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 1/37 (2.70%)  2
Urinary tract infection  1  0/76 (0.00%)  0 1/39 (2.56%)  1 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Injury, poisoning and procedural complications             
Arthropod bite  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Contusion  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Fall  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Joint injury  1  0/76 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Limb injury  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Tooth fracture  1  0/76 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Investigations             
Blood creatine phosphokinase increased  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Blood creatinine increased  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Blood glucose increased  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Computerised tomogram abnormal  1  0/76 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Electrocardiogram qt prolonged  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Glomerular filtration rate decreased  1  1/76 (1.32%)  1 0/39 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Hepatic enzyme increased  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Metabolism and nutrition disorders             
Hypercholesterolaemia  1  0/76 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Type 2 diabetes mellitus  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 1/38 (2.63%)  1 0/37 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Back pain  1  2/76 (2.63%)  2 1/39 (2.56%)  1 1/38 (2.63%)  1 0/38 (0.00%)  0 1/38 (2.63%)  2 1/37 (2.70%)  2
Bursitis  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Muscle spasms  1  2/76 (2.63%)  2 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Musculoskeletal pain  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Neck pain  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/37 (2.70%)  1
Pain in extremity  1  2/76 (2.63%)  3 3/39 (7.69%)  3 1/38 (2.63%)  1 0/38 (0.00%)  0 2/38 (5.26%)  2 0/37 (0.00%)  0
Rotator cuff syndrome  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Synovial cyst  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Basal cell carcinoma  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Benign breast neoplasm  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Nervous system disorders             
Burning sensation  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Convulsion  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Dizziness  1  2/76 (2.63%)  2 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Headache  1  2/76 (2.63%)  5 1/39 (2.56%)  3 0/38 (0.00%)  0 1/38 (2.63%)  1 1/38 (2.63%)  3 3/37 (8.11%)  3
Psychiatric disorders             
Depressed mood  1  0/76 (0.00%)  0 1/39 (2.56%)  2 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Seasonal affective disorder  1  0/76 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Renal and urinary disorders             
Polyuria  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 1/37 (2.70%)  1
Oropharyngeal pain  1  2/76 (2.63%)  2 0/39 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/37 (0.00%)  0
Respiratory tract congestion  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Upper respiratory tract congestion  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Skin and subcutaneous tissue disorders             
Alopecia  1  0/76 (0.00%)  0 0/39 (0.00%)  0 1/38 (2.63%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Erythema  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Pruritus  1  0/76 (0.00%)  0 1/39 (2.56%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Rash  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Urticaria  1  1/76 (1.32%)  1 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Surgical and medical procedures             
Tooth extraction  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  1 0/37 (0.00%)  0
Vascular disorders             
Hypertension  1  1/76 (1.32%)  1 1/39 (2.56%)  1 0/38 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 0/37 (0.00%)  0
Peripheral arterial occlusive disease  1  0/76 (0.00%)  0 0/39 (0.00%)  0 0/38 (0.00%)  0 0/38 (0.00%)  0 1/38 (2.63%)  2 0/37 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02192190     History of Changes
Other Study ID Numbers: 15515
I5Q-MC-CGAF ( Other Identifier: Eli Lilly and Company )
First Submitted: July 14, 2014
First Posted: July 16, 2014
Results First Submitted: October 8, 2018
Results First Posted: November 8, 2018
Last Update Posted: November 8, 2018