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Trial record 15 of 29 for:    LY2439821

A Study in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01253265
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: LY2439821
Drug: Placebo
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 30 Milligram (mg) LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821 Placebo
Hide Arm/Group Description Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10 Placebo is administered subcutaneously in the same manner as active drug in each dose group
Period Title: Overall Study
Started 6 6 6 6 8
Completed 5 6 6 6 7
Not Completed 1 0 0 0 1
Reason Not Completed
Met Predefined Discontinuation Criteria             1             0             0             0             0
Withdrawal by Subject             0             0             0             0             1
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821 Placebo Total
Hide Arm/Group Description Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10 Placebo is administered subcutaneously in the same manner as active drug in each dose group Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 8 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
53.0  (15.4) 56.8  (7.2) 61.7  (11.3) 52.5  (14.0) 60.1  (7.7) 57.0  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
Female
4
  66.7%
6
 100.0%
3
  50.0%
4
  66.7%
5
  62.5%
22
  68.8%
Male
2
  33.3%
0
   0.0%
3
  50.0%
2
  33.3%
3
  37.5%
10
  31.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
6 6 6 6 8 32
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
6 6 6 6 8 32
C-Reactive Protein (CRP)  
Median (Full Range)
Unit of measure:  Milligrams per liter (mg/L)
Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
7.950
(5.00 to 25.10)
11.750
(2.00 to 50.10)
3.500
(2.80 to 12.80)
31.000
(9.30 to 95.20)
5.650
(1.10 to 50.10)
9.700
(1.10 to 95.20)
Erythrocyte Sedimentation Rate (ESR)  
Median (Full Range)
Unit of measure:  Millimeters per hour (mm/h)
Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
28.0
(7 to 87)
53.5
(23 to 107)
26.0
(4 to 50)
42.5
(22 to 81)
25.5
(9 to 48)
29.5
(4 to 107)
Neutrophils  
Median (Full Range)
Unit of measure:  10^9 cells per liter (GI/L)
Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
6.763
(3.13 to 7.67)
4.293
(2.59 to 11.12)
3.857
(2.59 to 5.26)
6.056
(4.63 to 7.56)
6.757
(4.14 to 8.97)
5.261
(2.59 to 11.12)
Lymphocytes  
Median (Full Range)
Unit of measure:  10^9 cells per liter (GI/L)
Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
0.993
(0.42 to 2.62)
1.156
(0.69 to 2.19)
1.187
(0.88 to 2.01)
1.379
(0.67 to 2.45)
1.295
(1.06 to 2.29)
1.275
(0.42 to 2.62)
Duration of Rheumatoid Arthritis (RA)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
10.9  (11.8) 7.9  (9.7) 6.8  (12.0) 5.6  (4.1) 3.6  (3.2) 6.8  (8.5)
Weekly dose of Methotrexate (MTX)  
Mean (Standard Deviation)
Unit of measure:  Milligrams per week (mg/wk)
Number Analyzed 6 participants 6 participants 6 participants 6 participants 8 participants 32 participants
8.33  (0.82) 8.33  (0.82) 8.00  (0.00) 9.00  (1.10) 9.06  (1.66) 8.58  (1.10)
1.Primary Outcome
Title Number of Participants With Clinically Significant Effects
Hide Description Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.
Time Frame Baseline up to 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821 Placebo
Hide Arm/Group Description:
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
Placebo is administered subcutaneously in the same manner as active drug in each dose group
Overall Number of Participants Analyzed 6 6 6 6 8
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events 0 0 0 0 0
Other Adverse Events 4 5 3 3 6
2.Secondary Outcome
Title Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein
Hide Description C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821 Placebo
Hide Arm/Group Description:
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
Placebo is administered subcutaneously in the same manner as active drug in each dose group
Overall Number of Participants Analyzed 6 6 6 6 8
Median (Full Range)
Unit of Measure: percentage change in C-Reactive Protein
-88.75
(-98.6 to -66.7)
-73.81
(-98.8 to 180.0)
-17.04
(-48.4 to 150.0)
-95.47
(-99.3 to 100.0)
-8.07
(-82.8 to 186.2)
3.Secondary Outcome
Title Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR)
Hide Description Erythrocyte Sedimentation Rate (ESR) is a disease related biomarker and measured in millimeters per hour (mm/h).
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821 Placebo
Hide Arm/Group Description:
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
Placebo is administered subcutaneously in the same manner as active drug in each dose group
Overall Number of Participants Analyzed 6 6 6 6 8
Median (Full Range)
Unit of Measure: percentage change in ESR
-44.50
(-80.0 to -16.7)
-35.05
(-76.1 to 13.3)
-3.75
(-37.9 to 100.0)
-73.08
(-92.7 to -5.6)
-12.62
(-54.5 to 137.5)
4.Secondary Outcome
Title Change From Baseline to 26 Week Endpoint in Neutrophil Counts
Hide Description [Not Specified]
Time Frame Baseline, 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821 Placebo
Hide Arm/Group Description:
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
Placebo is administered subcutaneously in the same manner as active drug in each dose group
Overall Number of Participants Analyzed 6 6 6 6 8
Median (Full Range)
Unit of Measure: 10^9 cells per liter (GI/L)
0.681
(-5.77 to 5.84)
-0.559
(-2.62 to 5.62)
-0.170
(-0.87 to 2.72)
-2.677
(-2.87 to -0.70)
-0.641
(-2.94 to 2.29)
5.Secondary Outcome
Title Change From Baseline to 26 Week Endpoint in Lymphocyte Counts
Hide Description [Not Specified]
Time Frame Baseline, 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821 Placebo
Hide Arm/Group Description:
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
Placebo is administered subcutaneously in the same manner as active drug in each dose group
Overall Number of Participants Analyzed 6 6 6 6 8
Median (Full Range)
Unit of Measure: 10^9 cells per liter (GI/L)
0.189
(-1.19 to 1.23)
-0.011
(-0.54 to 1.25)
-0.184
(-0.37 to 0.09)
0.138
(-0.15 to 0.65)
0.085
(-0.56 to 0.24)
6.Secondary Outcome
Title Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss)
Hide Description AUCτ,ss= area under the concentration versus time curve (τ) at steady state (ss)
Time Frame Week 10 pre-dose up to 2 weeks post-dose (Week 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with analyzable pharmacokinetic data.
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821
Hide Arm/Group Description:
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
Overall Number of Participants Analyzed 5 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms•day per milliliter(μg•day/mL)
77.2
(26%)
151
(44%)
437
(42%)
208
(48%)
7.Secondary Outcome
Title Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss)
Hide Description Cmax,ss = maximum observed drug concentration (Cmax) at steady state (ss)
Time Frame Week 10 pre-dose up to 2 weeks post-dose (Week 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with analyzable pharmacokinetic data.
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821
Hide Arm/Group Description:
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
Overall Number of Participants Analyzed 5 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (μg/mL)
7.05
(26%)
13.5
(43%)
39.3
(42%)
33.1
(56%)
8.Secondary Outcome
Title Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss)
Hide Description tmax,ss = time of maximum observed drug concentration (tmax) at steady state (ss)
Time Frame Week 10 pre-dose up to 2 weeks post-dose (Week 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with analyzable pharmacokinetic data.
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821
Hide Arm/Group Description:
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
Overall Number of Participants Analyzed 5 6 6 6
Median (Full Range)
Unit of Measure: days
1.96
(1.91 to 7.00)
1.93
(1.89 to 3.97)
1.95
(1.88 to 2.02)
3.89
(1.93 to 3.99)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821 Placebo
Hide Arm/Group Description Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10 Placebo is administered subcutaneously in the same manner as active drug in each dose group
All-Cause Mortality
30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
30 mg LY2439821 80 mg LY2439821 180 mg LY2439821 120 mg LY2439821 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/6 (66.67%)      5/6 (83.33%)      3/6 (50.00%)      3/6 (50.00%)      6/8 (75.00%)    
Eye disorders           
Eyelid oedema  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 0/8 (0.00%)  0
Ocular hyperaemia  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Gastrointestinal disorders           
Dry mouth  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Mouth ulceration  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Nausea  1  1/6 (16.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
General disorders           
Administration site reaction  1  0/6 (0.00%)  0 1/6 (16.67%)  5 0/6 (0.00%)  0 1/6 (16.67%)  3 0/8 (0.00%)  0
Feeling abnormal  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Injection site erythema  1  1/6 (16.67%)  3 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 0/8 (0.00%)  0
Hepatobiliary disorders           
Cholelithiasis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0
Hepatic function abnormal  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations           
Cystitis  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1
Gastroenteritis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0
Herpes zoster  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1
Molluscum contagiosum  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1
Nasopharyngitis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/8 (25.00%)  2
Pharyngitis  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Upper respiratory tract infection  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Injury, poisoning and procedural complications           
Bite  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Contusion  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Fall  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Heat illness  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Joint dislocation  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Limb injury  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Investigations           
Blood creatine phosphokinase increased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1
Blood pressure decreased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Blood pressure increased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  3 0/6 (0.00%)  0 0/8 (0.00%)  0
Blood urine present  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Lymphocyte count decreased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1
Protein urine present  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/6 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Arthritis  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Rheumatoid arthritis  1  1/6 (16.67%)  1 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 3/8 (37.50%)  3
Nervous system disorders           
Headache  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Migraine  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Renal and urinary disorders           
Renal cyst  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0
Renal impairment  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1
Reproductive system and breast disorders           
Menopausal symptoms  1  1/4 (25.00%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Oropharyngeal pain  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Upper respiratory tract inflammation  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Surgical and medical procedures           
Cataract operation  1  0/6 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Pain prophylaxis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  3 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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: NCT01253265     History of Changes
Other Study ID Numbers: 13061
I1F-JE-RHAL ( Other Identifier: Eli Lilly and Company )
First Submitted: December 1, 2010
First Posted: December 3, 2010
Results First Submitted: April 20, 2016
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016