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A Study of LY2484595 in Patients With High LDL-C or Low HDL-C

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: NCT01105975
Recruitment Status : Completed
First Posted : April 19, 2010
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dyslipidemia
Interventions Drug: LY2484595
Drug: Atorvastatin
Drug: Simvastatin
Drug: Rosuvastatin
Drug: Placebo for LY2484595
Drug: Placebo for Statins
Enrollment 398
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks
Period Title: Overall Study
Started 40 39 42 38 41 35 42 40 40 41
Took at Least One Dose of Study Drug 40 38 40 38 41 35 41 40 39 41
Completed 35 34 32 36 35 30 34 33 34 32
Not Completed 5 5 10 2 6 5 8 7 6 9
Reason Not Completed
Adverse Event             2             1             5             1             0             1             2             4             1             4
Withdrawal by Subject             2             2             2             0             4             1             2             1             0             3
Lost to Follow-up             1             0             0             1             1             0             0             0             1             0
Physician Decision             0             0             0             0             0             0             2             0             0             0
Protocol Violation             0             2             2             0             1             1             1             1             2             2
Abnormal Lab/Electrocardiogram Result             0             0             1             0             0             2             1             1             2             0
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin Total
Hide Arm/Group Description Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 40 38 40 38 41 35 41 40 39 41 393
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 38 participants 40 participants 38 participants 41 participants 35 participants 41 participants 40 participants 39 participants 41 participants 393 participants
58.5  (11.1) 58.5  (9.2) 58.8  (12.2) 55.2  (10.5) 57.8  (11.3) 57.4  (11.8) 61.3  (10.0) 58.4  (9.0) 57.4  (12.6) 59.7  (10.1) 58.3  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 38 participants 40 participants 38 participants 41 participants 35 participants 41 participants 40 participants 39 participants 41 participants 393 participants
Female
23
  57.5%
22
  57.9%
21
  52.5%
20
  52.6%
26
  63.4%
18
  51.4%
29
  70.7%
25
  62.5%
13
  33.3%
23
  56.1%
220
  56.0%
Male
17
  42.5%
16
  42.1%
19
  47.5%
18
  47.4%
15
  36.6%
17
  48.6%
12
  29.3%
15
  37.5%
26
  66.7%
18
  43.9%
173
  44.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 38 participants 40 participants 38 participants 41 participants 35 participants 41 participants 40 participants 39 participants 41 participants 393 participants
Hispanic or Latino
2
   5.0%
3
   7.9%
2
   5.0%
3
   7.9%
2
   4.9%
2
   5.7%
2
   4.9%
1
   2.5%
1
   2.6%
1
   2.4%
19
   4.8%
Not Hispanic or Latino
27
  67.5%
28
  73.7%
29
  72.5%
26
  68.4%
29
  70.7%
25
  71.4%
29
  70.7%
30
  75.0%
25
  64.1%
34
  82.9%
282
  71.8%
Unknown or Not Reported
11
  27.5%
7
  18.4%
9
  22.5%
9
  23.7%
10
  24.4%
8
  22.9%
10
  24.4%
9
  22.5%
13
  33.3%
6
  14.6%
92
  23.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 38 participants 40 participants 38 participants 41 participants 35 participants 41 participants 40 participants 39 participants 41 participants 393 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%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
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%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  12.5%
1
   2.6%
4
  10.0%
1
   2.6%
1
   2.4%
2
   5.7%
2
   4.9%
0
   0.0%
3
   7.7%
1
   2.4%
20
   5.1%
White
33
  82.5%
36
  94.7%
35
  87.5%
36
  94.7%
39
  95.1%
33
  94.3%
39
  95.1%
39
  97.5%
35
  89.7%
40
  97.6%
365
  92.9%
More than one race
1
   2.5%
1
   2.6%
1
   2.5%
1
   2.6%
1
   2.4%
0
   0.0%
0
   0.0%
1
   2.5%
1
   2.6%
0
   0.0%
7
   1.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 38 participants 40 participants 38 participants 41 participants 35 participants 41 participants 40 participants 39 participants 41 participants 393 participants
United States 22 23 22 22 23 18 21 23 22 22 218
Poland 2 2 2 0 2 1 1 2 0 4 16
Denmark 12 9 8 10 10 9 12 11 11 10 102
Germany 2 1 1 1 2 1 0 1 2 0 11
Netherlands 2 2 5 5 4 5 6 2 4 4 39
United Kingdom 0 1 2 0 0 1 1 1 0 1 7
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 40 participants 38 participants 40 participants 38 participants 41 participants 35 participants 41 participants 40 participants 39 participants 41 participants 393 participants
84.6  (23.2) 79.9  (18.3) 82.6  (20.6) 89.3  (18.5) 81.4  (16.4) 87.4  (22.4) 79.6  (15.4) 84.5  (16.7) 85.7  (19.4) 82.2  (18.0) 83.6  (19.0)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram/square meter (kg/m²)
Number Analyzed 40 participants 38 participants 40 participants 38 participants 41 participants 35 participants 41 participants 40 participants 39 participants 41 participants 393 participants
29.8  (7.8) 27.6  (5.7) 29.0  (5.6) 29.8  (6.1) 28.8  (5.1) 30.0  (7.5) 28.3  (5.0) 29.9  (5.3) 28.3  (4.2) 28.4  (5.3) 29.0  (5.8)
High-Density Lipoprotein Cholesterol (HDL-C)  
Mean (Standard Deviation)
Unit of measure:  Milligram/deciliter (mg/dL)
Number Analyzed 40 participants 38 participants 40 participants 38 participants 41 participants 35 participants 41 participants 40 participants 39 participants 41 participants 393 participants
54.7  (12.0) 57.0  (14.1) 54.7  (16.3) 53.0  (11.8) 53.9  (17.0) 55.7  (18.2) 57.3  (16.2) 53.7  (13.6) 53.5  (15.2) 57.8  (18.1) 55.1  (15.3)
Low-Density Lipoprotein Cholesterol (LDL-C)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 40 participants 38 participants 40 participants 38 participants 41 participants 35 participants 41 participants 40 participants 39 participants 41 participants 393 participants
143.5  (26.0) 148.0  (25.0) 135.7  (26.0) 147.3  (21.6) 139.0  (26.7) 143.6  (26.0) 154.8  (35.1) 143.7  (29.1) 141.6  (23.8) 145.7  (21.8) 144.3  (26.6)
Fasting Triglycerides  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 40 participants 38 participants 40 participants 38 participants 41 participants 35 participants 41 participants 40 participants 39 participants 41 participants 393 participants
133.9  (56.6) 129.8  (51.7) 133.1  (69.8) 154.4  (93.0) 144.1  (83.4) 133.0  (67.8) 145.3  (84.6) 142.4  (62.4) 142.8  (65.6) 138.1  (69.0) 139.8  (71.1)
1.Primary Outcome
Title Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 HDL-C measurements.
Arm/Group Title 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 34 31
Least Squares Mean (Standard Error)
Unit of Measure: percent change of mg/dL
1.4  (5.7) 79.9  (6.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg Atorvastatin Monotherapy, 100 mg LY2484595 + 20 mg Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 78.5
Confidence Interval (2-Sided) 90%
64.9 to 92.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 LDL-C measurements.
Arm/Group Title 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 35 31
Least Squares Mean (Standard Error)
Unit of Measure: percent change of mg/dL
-33.6  (3.0) -47.6  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg Atorvastatin Monotherapy, 100 mg LY2484595 + 20 mg Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.9
Confidence Interval (2-Sided) 90%
-21.2 to -6.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 HDL-C measurements.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 35 35 33 36
Least Squares Mean (Standard Error)
Unit of Measure: percent change of mg/dL
53.6  (5.6) 94.6  (5.7) 128.8  (5.8) -3.0  (5.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 30 mg LY2484595 Monotherapy, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 56.7
Confidence Interval (2-Sided) 90%
43.6 to 69.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 100 mg LY2484595 Monotherapy, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 97.6
Confidence Interval 90%
84.5 to 110.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 500 mg LY2484595 Monotherapy, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 131.9
Confidence Interval (2-Sided) 90%
118.5 to 145.2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 LDL-C measurements.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 35 35 33 36
Least Squares Mean (Standard Error)
Unit of Measure: percent change of mg/dL
-13.6  (3.0) -22.3  (3.0) -35.9  (3.1) 3.9  (3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 30 mg LY2484595 Monotherapy, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.6
Confidence Interval (2-Sided) 90%
-24.6 to -10.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 100 mg LY2484595 Monotherapy, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -26.2
Confidence Interval (2-Sided) 90%
-33.2 to -19.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 500 mg LY2484595 Monotherapy, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -39.8
Confidence Interval (2-Sided) 90%
-47.0 to -32.7
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 HDL-C measurements.
Arm/Group Title 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 36 33 35 33
Least Squares Mean (Standard Error)
Unit of Measure: percent change of mg/dL
7.3  (5.5) 86.6  (5.7) 5.5  (5.7) 94.0  (5.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40 mg Simvastatin Monotherapy, 100 mg LY2484595 + 40 mg Simvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 79.3
Confidence Interval 90%
66.2 to 92.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 10 mg Rosuvastatin Monotherapy, 100 mg LY2484595 + 10 mg Rosuvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 88.5
Confidence Interval (2-Sided) 90%
75.2 to 101.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 LDL-C measurements.
Arm/Group Title 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 36 33 35 33
Least Squares Mean (Standard Error)
Unit of Measure: percent change of mg/dL
-34.9  (3.0) -46.1  (3.1) -38.8  (3.0) -52.3  (3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 40 mg Simvastatin Monotherapy, 100 mg LY2484595 + 40 mg Simvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.2
Confidence Interval (2-Sided) 90%
-18.3 to -4.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 10 mg Rosuvastatin Monotherapy, 100 mg LY2484595 + 10 mg Rosuvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method mixed model repeated measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.5
Confidence Interval (2-Sided) 90%
-20.6 to -6.4
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State
Hide Description [Not Specified]
Time Frame Baseline up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered LY2484595 and had pharmacokinetics (PK) samples.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 100 mg LY2484595 + 40 mg Simvastatin 100 mg LY2484595 + 10 mg Rosuvastatin
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Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 39 38 40 35 40 41
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
2300
(39.4%)
5900
(39.4%)
19700
(39.4%)
5500
(39.4%)
5620
(39.4%)
5960
(39.4%)
8.Secondary Outcome
Title Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
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Hide Analysis Population Description
Participants who had both baseline and Week 12 CETP activity measurements.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 35 33 31 35 34 30 33 32 34 30
Least Squares Mean (Standard Error)
Unit of Measure: percent change of picomoles/mL/minute
-49.48  (3.75) -70.80  (3.89) -89.10  (4.00) 12.12  (3.75) -0.01  (3.81) -72.00  (4.01) -2.23  (3.80) -64.64  (3.86) -7.19  (3.80) -73.24  (3.96)
9.Secondary Outcome
Title Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 CETP mass measurements.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 35 35 32 36 36 31 35 33 34 30
Least Squares Mean (Standard Error)
Unit of Measure: percent change of micrograms/mL (mcg/mL)
63.94  (5.54) 92.27  (5.59) 136.66  (5.83) 0.58  (5.51) -11.8  (5.48) 62.98  (5.87) -11.14  (5.50) 65.92  (5.63) -16.58  (5.62) 64.08  (5.81)
10.Secondary Outcome
Title The Number of Episodes of Rashes at Any Time From Baseline Through Week 12
Hide Description All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories.
Time Frame Baseline through Week 12
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Hide Analysis Population Description
Participants who took study drug.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 40 38 40 38 41 35 41 40 39 41
Measure Type: Number
Unit of Measure: events
High Risk (HR)- Angioedema 0 0 0 0 0 0 1 0 0 0
HR - Insufficient Documentation for Determination 0 0 0 0 0 0 0 0 0 1
Low Risk 0 0 0 0 0 0 0 1 0 2
Not a Relevant Dermatoses 4 5 3 0 1 2 6 4 0 1
Insufficient Documentation for Determination 0 0 0 0 0 0 0 0 0 0
11.Secondary Outcome
Title Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 BP measurements.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 35 35 33 36 36 30 35 33 35 33
Least Squares Mean (Standard Error)
Unit of Measure: millimeters of mercury (mmHg)
Diastolic BP 1.1  (1.1) 0.8  (1.1) 1.2  (1.2) 1.6  (1.1) 0.2  (1.1) 1.2  (1.2) -1.5  (1.1) 2.3  (1.2) 2.2  (1.1) -0.1  (1.1)
Systolic BP 4.4  (1.8) 4.3  (1.8) 1.4  (1.8) 2.8  (1.7) 0.2  (1.7) 2.1  (1.9) 0.0  (1.7) 2.3  (1.8) 0.0  (1.8) 3.8  (1.8)
12.Secondary Outcome
Title Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 aldosterone measurements.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 34 35 33 36 35 31 35 33 34 32
Least Squares Mean (Standard Error)
Unit of Measure: nanogram/deciliter (ng/dL)
-0.5  (0.9) 1.0  (0.9) -0.3  (0.9) -1.0  (0.9) -1.0  (0.9) 0.4  (0.9) 0.0  (0.9) -1.7  (0.9) -2.5  (0.9) 0.0  (0.9)
13.Secondary Outcome
Title Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 renin activity measurements.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 33 33 32 34 33 28 33 32 35 29
Least Squares Mean (Standard Error)
Unit of Measure: nanograms/milliliter/hour (ng/mL/h)
-0.06  (0.34) -0.11  (0.34) -0.58  (0.35) -0.30  (0.34) -0.58  (0.34) -0.26  (0.37) -0.16  (0.34) 0.00  (0.34) -0.86  (0.33) -0.29  (0.35)
14.Secondary Outcome
Title Change From Baseline to 12 Weeks Endpoint in Serum Potassium
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 potassium measurements.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 35 35 33 36 35 31 36 33 35 33
Least Squares Mean (Standard Error)
Unit of Measure: milliequivalents/Liter
-0.04  (0.05) 0.01  (0.05) -0.02  (0.05) -0.08  (0.05) 0.09  (0.05) 0.08  (0.05) 0.03  (0.05) 0.02  (0.05) -0.07  (0.05) -0.05  (0.05)
15.Secondary Outcome
Title Change From Baseline to 12 Weeks Endpoint in Serum Sodium
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 sodium measurements.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 35 35 33 36 35 31 36 33 35 33
Least Squares Mean (Standard Error)
Unit of Measure: milliequivalents/Liter
0.3  (0.4) 0.3  (0.4) 0.5  (0.4) 0.1  (0.4) 1.3  (0.4) 0.6  (0.4) 0.8  (0.4) 0.9  (0.4) 0.5  (0.4) 0.3  (0.4)
16.Secondary Outcome
Title Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate
Hide Description Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and Week 12 bicarbonate measurements.
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 34 35 32 35 34 31 36 33 35 33
Least Squares Mean (Standard Error)
Unit of Measure: milliequivalents/Liter
0.40  (0.36) 0.60  (0.36) 0.51  (0.37) 0.27  (0.36) 0.10  (0.36) 0.58  (0.38) 1.04  (0.35) 0.58  (0.37) 0.78  (0.36) 1.25  (0.37)
17.Secondary Outcome
Title Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score
Hide Description EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. LS Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Time Frame Baseline up to Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both baseline and at least one post-baseline EQ-5D measurements, last observation carried forward (LOCF).
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin
Hide Arm/Group Description:
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Administered daily by mouth for 12 weeks
Overall Number of Participants Analyzed 37 36 39 36 39 35 39 40 39 41
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.008  (0.014) 0.002  (0.014) 0.012  (0.014) -0.001  (0.014) -0.002  (0.014) -0.006  (0.014) -0.001  (0.014) -0.001  (0.013) 0.014  (0.014) -0.047  (0.013)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin 30 mg LY2484595 Monotherapy Follow-Up 100 mg LY2484595 Monotherapy Follow-Up 500 mg LY2484595 Monotherapy Follow-Up Placebo Follow-Up 20 mg Atorvastatin Monotherapy Follow-Up 100 mg LY2484595 + 20 mg Atorvastatin Follow-Up 40 mg Simvastatin Monotherapy Follow-Up 100 mg LY2484595 + 40 mg Simvastatin Follow-Up 10 mg Rosuvastatin Monotherapy Follow-Up 100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up
Hide Arm/Group Description Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks Administered daily by mouth for 12 weeks 30 day follow-up period after last dose of study drug 30 day follow-up period after last dose of study drug 30 day follow-up period after last dose of study drug 30 day follow-up period after last dose of study drug 30 day follow-up period after last dose of study drug 30 day follow-up period after last dose of study drug 30 day follow-up period after last dose of study drug 30 day follow-up period after last dose of study drug 30 day follow-up period after last dose of study drug 30 day follow-up period after last dose of study drug
All-Cause Mortality
30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin 30 mg LY2484595 Monotherapy Follow-Up 100 mg LY2484595 Monotherapy Follow-Up 500 mg LY2484595 Monotherapy Follow-Up Placebo Follow-Up 20 mg Atorvastatin Monotherapy Follow-Up 100 mg LY2484595 + 20 mg Atorvastatin Follow-Up 40 mg Simvastatin Monotherapy Follow-Up 100 mg LY2484595 + 40 mg Simvastatin Follow-Up 10 mg Rosuvastatin Monotherapy Follow-Up 100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) 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
30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin 30 mg LY2484595 Monotherapy Follow-Up 100 mg LY2484595 Monotherapy Follow-Up 500 mg LY2484595 Monotherapy Follow-Up Placebo Follow-Up 20 mg Atorvastatin Monotherapy Follow-Up 100 mg LY2484595 + 20 mg Atorvastatin Follow-Up 40 mg Simvastatin Monotherapy Follow-Up 100 mg LY2484595 + 40 mg Simvastatin Follow-Up 10 mg Rosuvastatin Monotherapy Follow-Up 100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   0/40 (0.00%)      0/38 (0.00%)      1/40 (2.50%)      0/38 (0.00%)      0/41 (0.00%)      1/35 (2.86%)      1/41 (2.44%)      0/40 (0.00%)      0/39 (0.00%)      1/41 (2.44%)      0/40 (0.00%)      0/38 (0.00%)      1/40 (2.50%)      1/38 (2.63%)      0/41 (0.00%)      0/35 (0.00%)      0/41 (0.00%)      0/40 (0.00%)      0/39 (0.00%)      0/41 (0.00%)    
Cardiac disorders                                         
Coronary artery disease  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Infections and infestations                                         
Influenza  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 1/38 (2.63%)  1 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Injury, poisoning and procedural complications                                         
Fall  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Hip fracture  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Upper limb fracture  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Musculoskeletal and connective tissue disorders                                         
Bursitis  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 1/40 (2.50%)  1 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                                         
Anal cancer  1  0/40 (0.00%)  0 0/38 (0.00%)  0 1/40 (2.50%)  1 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Metastases to lymph nodes  1  0/40 (0.00%)  0 0/38 (0.00%)  0 1/40 (2.50%)  1 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
30 mg LY2484595 Monotherapy 100 mg LY2484595 Monotherapy 500 mg LY2484595 Monotherapy Placebo 20 mg Atorvastatin Monotherapy 100 mg LY2484595 + 20 mg Atorvastatin 40 mg Simvastatin Monotherapy 100 mg LY2484595 + 40 mg Simvastatin 10 mg Rosuvastatin Monotherapy 100 mg LY2484595 + 10 mg Rosuvastatin 30 mg LY2484595 Monotherapy Follow-Up 100 mg LY2484595 Monotherapy Follow-Up 500 mg LY2484595 Monotherapy Follow-Up Placebo Follow-Up 20 mg Atorvastatin Monotherapy Follow-Up 100 mg LY2484595 + 20 mg Atorvastatin Follow-Up 40 mg Simvastatin Monotherapy Follow-Up 100 mg LY2484595 + 40 mg Simvastatin Follow-Up 10 mg Rosuvastatin Monotherapy Follow-Up 100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   22/40 (55.00%)      25/38 (65.79%)      21/40 (52.50%)      23/38 (60.53%)      29/41 (70.73%)      22/35 (62.86%)      29/41 (70.73%)      27/40 (67.50%)      31/39 (79.49%)      27/41 (65.85%)      7/40 (17.50%)      4/38 (10.53%)      6/40 (15.00%)      8/38 (21.05%)      6/41 (14.63%)      8/35 (22.86%)      7/41 (17.07%)      4/40 (10.00%)      6/39 (15.38%)      5/41 (12.20%)    
Cardiac disorders                                         
Atrial fibrillation  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 1/40 (2.50%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Atrioventricular block first degree  1  0/40 (0.00%)  0 0/38 (0.00%)  0 1/40 (2.50%)  2 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Myocardial infarction  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0
Palpitations  1  0/40 (0.00%)  0 2/38 (5.26%)  2 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Sinus bradycardia  1  0/40 (0.00%)  0 0/38 (0.00%)  0 1/40 (2.50%)  1 0/38 (0.00%)  0 1/41 (2.44%)  1 1/35 (2.86%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Ventricular extrasystoles  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Ear and labyrinth disorders                                         
Cerumen impaction  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 1/39 (2.56%)  1 1/41 (2.44%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Ear haemorrhage  1  0/40 (0.00%)  0 1/38 (2.63%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Middle ear inflammation  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Tinnitus  1  1/40 (2.50%)  1 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 1/39 (2.56%)  2 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 1/41 (2.44%)  1 1/35 (2.86%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Vertigo  1  0/40 (0.00%)  0 0/38 (0.00%)  0 1/40 (2.50%)  1 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Eye disorders                                         
Borderline glaucoma  1  1/40 (2.50%)  1 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Conjunctival haemorrhage  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Conjunctivitis allergic  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Eyelid ptosis  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Photopsia  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 1/41 (2.44%)  1 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Vitreous detachment  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Vitreous floaters  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 1/41 (2.44%)  1 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Gastrointestinal disorders                                         
Abdominal discomfort  1  0/40 (0.00%)  0 1/38 (2.63%)  1 1/40 (2.50%)  1 2/38 (5.26%)  2 1/41 (2.44%)  1 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Abdominal distension  1  0/40 (0.00%)  0 0/38 (0.00%)  0 1/40 (2.50%)  1 1/38 (2.63%)  1 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Abdominal pain  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 1/41 (2.44%)  1 1/35 (2.86%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Abdominal pain upper  1  1/40 (2.50%)  1 1/38 (2.63%)  1 2/40 (5.00%)  2 1/38 (2.63%)  1 2/41 (4.88%)  2 1/35 (2.86%)  1 0/41 (0.00%)  0 1/40 (2.50%)  1 0/39 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Aphthous stomatitis  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Constipation  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 2/41 (4.88%)  2 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Diarrhoea  1  0/40 (0.00%)  0 2/38 (5.26%)  2 3/40 (7.50%)  3 1/38 (2.63%)  1 1/41 (2.44%)  1 2/35 (5.71%)  2 1/41 (2.44%)  1 2/40 (5.00%)  2 2/39 (5.13%)  2 2/41 (4.88%)  2 1/40 (2.50%)  1 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 1/41 (2.44%)  1 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0
Diarrhoea haemorrhagic  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Diverticulum  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Diverticulum intestinal  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Dry mouth  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 1/38 (2.63%)  1 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Dyspepsia  1  2/40 (5.00%)  2 0/38 (0.00%)  0 1/40 (2.50%)  1 1/38 (2.63%)  1 0/41 (0.00%)  0 1/35 (2.86%)  1 2/41 (4.88%)  2 0/40 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0 1/40 (2.50%)  1 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Faecal incontinence  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Flatulence  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 2/38 (5.26%)  2 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 1/40 (2.50%)  1 0/39 (0.00%)  0 3/41 (7.32%)  3 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Frequent bowel movements  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 1/38 (2.63%)  1 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Gastritis atrophic  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Gastrointestinal disorder  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Gastrooesophageal reflux disease  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 1/38 (2.63%)  1 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 1/40 (2.50%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Gingival bleeding  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Gingivitis  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Haemorrhoids  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Hypoaesthesia oral  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 1/40 (2.50%)  1 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Infrequent bowel movements  1  1/40 (2.50%)  1 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Inguinal hernia  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 1/41 (2.44%)  1 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Lip swelling  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Nausea  1  0/40 (0.00%)  0 0/38 (0.00%)  0 3/40 (7.50%)  3 1/38 (2.63%)  1 1/41 (2.44%)  1 3/35 (8.57%)  3 1/41 (2.44%)  1 2/40 (5.00%)  2 1/39 (2.56%)  1 4/41 (9.76%)  5 1/40 (2.50%)  1 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Paraesthesia oral  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Periodontitis  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 1/39 (2.56%)  1 0/41 (0.00%)  0
Stomatitis  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Toothache  1  0/40 (0.00%)  0 1/38 (2.63%)  1 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 1/41 (2.44%)  1 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)  0 0/41 (0.00%)  0 0/35 (0.00%)  0 0/41 (0.00%)  0 0/40 (0.00%)  0 0/39 (0.00%)  0 0/41 (0.00%)  0
Vomiting  1  0/40 (0.00%)  0 0/38 (0.00%)  0 0/40 (0.00%)  0 0/38 (0.00%)