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Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities (TESLA)

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ClinicalTrials.gov Identifier: NCT01588496
Recruitment Status : Completed
First Posted : May 1, 2012
Results First Posted : October 2, 2015
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Homozygous Familial Hypercholesterolemia
Interventions Biological: Evolocumab
Drug: Placebo
Enrollment 58
Recruitment Details Male and female adults and adolescents ages ≥ 12 to ≤ 65 years (≥ 12 to ≤ 80 years in Part B) with a diagnosis of homozygous familial hypercholesterolemia (HoFH) were eligible for this study. The first participant enrolled on 05 April 2012 and the last participant enrolled on 08 November 2013.
Pre-assignment Details Part A was an open-label, single-arm, multicenter pilot study. Part B was a double-blind, randomized, placebo-controlled, multicenter study with expanded enrollment. In Part B participants were randomized in a 1:2 allocation stratified on the basis of screening low-density lipoprotein cholesterol (LDL-C) (< 420 mg/dL vs ≥ 420 mg/dL).
Arm/Group Title Part A: Evolocumab Part B: Placebo Part B: Evolocumab
Hide Arm/Group Description Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks. Participants received double-blind placebo subcutaneously once a month for 12 weeks. Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
Period Title: Overall Study
Started 8 17 33
Received Treatment 8 16 33
Completed 8 16 33
Not Completed 0 1 0
Reason Not Completed
Withdrawal by Subject             0             1             0
Arm/Group Title Part A: Evolocumab Part B: Placebo Part B: Evolocumab Total
Hide Arm/Group Description Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks. Participants received double-blind placebo subcutaneously once a month for 12 weeks. Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 8 17 33 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 17 participants 33 participants 58 participants
34.3  (12.4) 32.8  (13.7) 30.3  (12.4) 31.6  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 17 participants 33 participants 58 participants
Female
2
  25.0%
8
  47.1%
16
  48.5%
26
  44.8%
Male
6
  75.0%
9
  52.9%
17
  51.5%
32
  55.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 17 participants 33 participants 58 participants
American Indian or Alaska Native 0 0 0 0
Asian 0 1 1 2
Black or African American 0 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0 0
White 8 16 29 53
Other 0 0 3 3
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 17 participants 33 participants 58 participants
Hispanic or Latino 0 0 1 1
Not Hispanic or Latino 8 17 32 57
Stratification Factor: Low-Density Lipoprotein Cholesterol (LDL-C) Level   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 17 participants 33 participants 58 participants
< 420 mg/dL 0 11 21 32
≥ 420 mg/dL 0 6 12 18
Missing 8 0 0 8
[1]
Measure Description: Participants in Part A were not stratified based on LDL-C level.
LDL-C Concentration   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 17 participants 33 participants 58 participants
Part A 441.7  (113.3) NA [2]   (NA) NA [2]   (NA) 441.7  (113.3)
Part B NA [3]   (NA) 335.8  (146.0) 356.0  (134.5) 349.4  (137.2)
[1]
Measure Description: LDL-C was quantified using the ultracentrifugation method. Data are provided for the full analysis set (all enrolled participants who received at least 1 dose of evolocumab (Part A) or all randomized participants who received at least 1 dose of investigational product (Part B).
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 17 participants 33 participants 58 participants
Part A 470.6  (117.8) NA [2]   (NA) NA [2]   (NA) 470.6  (117.8)
Part B NA [3]   (NA) 358.9  (149.1) 374.9  (136.9) 369.7  (139.6)
[1]
Measure Description: Data are provided for the full analysis set
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
Apolipoprotein B Concentration   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 8 participants 17 participants 33 participants 58 participants
Part A 269.1  (53.0) NA [2]   (NA) NA [2]   (NA) 269.1  (53.0)
Part B NA [3]   (NA) 208.6  (79.5) 208.3  (68.4) 208.4  (71.4)
[1]
Measure Description: Data are provided for the full analysis set
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
Total Cholesterol/HDL-C Ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 8 participants 17 participants 33 participants 58 participants
Part A 15.988  (5.107) NA [2]   (NA) NA [2]   (NA) 15.988  (5.107)
Part B NA [3]   (NA) 12.101  (6.619) 11.972  (6.387) 12.014  (6.395)
[1]
Measure Description: Data are provided for the full analysis set
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
Apolipoprotein B/Apolipoprotein A1 Ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 8 participants 17 participants 33 participants 58 participants
Part A 2.800  (0.729) NA [2]   (NA) NA [2]   (NA) 2.800  (0.729)
Part B NA [3]   (NA) 2.053  (0.967) 2.098  (1.046) 2.084  (1.011)
[1]
Measure Description: Data are provided for the full analysis set
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
Lipoprotein(a) Concentration  
Median (Inter-Quartile Range)
Unit of measure:  nmol/L
Number Analyzed 8 participants 17 participants 33 participants 58 participants
Part A
246.5
(61.5 to 276)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
246.5
(61.5 to 276)
Part B
NA [2] 
(NA to NA)
127.5
(79.5 to 200.5)
76.0
(25.5 to 145.0)
100.5
(31.0 to 146.0)
[1]
Not applicable for Part B participants
[2]
Not applicable for Part A participants
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Concentration   [1] 
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 8 participants 17 participants 33 participants 58 participants
Part A 598.6  (121.1) NA [2]   (NA) NA [2]   (NA) 598.6  (121.1)
Part B NA [3]   (NA) 674.2  (180.0) 640.3  (207.5) 651.4  (197.7)
[1]
Measure Description: Data are provided for the full analysis set
[2]
Not applicable for Part B participants
[3]
Not applicable for Part A participants
1.Primary Outcome
Title Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Hide Description LDL-C was quantified using the ultracentrifugation method.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A full analysis set (all enrolled participants who received at least 1 dose of evolocumab)
Arm/Group Title Part A: Evolocumab
Hide Arm/Group Description:
Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: percent change
-16.5  (6.7)
2.Primary Outcome
Title Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Hide Description LDL-C was quantified using the ultracentrifugation method.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part B full analysis set (all enrolled participants who received at least 1 dose of investigational product)
Arm/Group Title Part B: Placebo Part B: Evolocumab
Hide Arm/Group Description:
Participants received double-blind placebo subcutaneously once a month for 12 weeks.
Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
Overall Number of Participants Analyzed 16 33
Least Squares Mean (Standard Error)
Unit of Measure: percent change
7.88  (5.26) -23.05  (3.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Evolocumab
Comments LDL-C lowering was analyzed by comparing evolocumab and placebo. Statistical analysis was 2-sided with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -30.93
Confidence Interval (2-Sided) 95%
-43.86 to -18.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.42
Estimation Comments Placebo is the reference
3.Secondary Outcome
Title Part A: Change From Baseline in LDL-C at Week 12
Hide Description LDL-C was quantified using the ultracentrifugation method.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A full analysis set
Arm/Group Title Part A: Evolocumab
Hide Arm/Group Description:
Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: mg/dL
-70.6  (32.3)
4.Secondary Outcome
Title Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A full analysis set
Arm/Group Title Part A: Evolocumab
Hide Arm/Group Description:
Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: percent change
-16.6  (6.5)
5.Secondary Outcome
Title Part A: Percent Change From Baseline in Apolipoprotein B at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A full analysis set
Arm/Group Title Part A: Evolocumab
Hide Arm/Group Description:
Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: percent change
-14.9  (5.0)
6.Secondary Outcome
Title Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A full analysis set
Arm/Group Title Part A: Evolocumab
Hide Arm/Group Description:
Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: percent change
-18.319  (6.058)
7.Secondary Outcome
Title Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A full analysis set
Arm/Group Title Part A: Evolocumab
Hide Arm/Group Description:
Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: percent change
-15.65  (4.690)
8.Secondary Outcome
Title Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12
Hide Description LDL-C was quantified using the ultracentrifugation method.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A full analysis set
Arm/Group Title Part A: Evolocumab
Hide Arm/Group Description:
Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of participants
50.0
9.Secondary Outcome
Title Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part A full analysis set
Arm/Group Title Part A: Evolocumab
Hide Arm/Group Description:
Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: ng/mL
-151.3  (81.7)
10.Secondary Outcome
Title Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12
Hide Description LDL-C was quantified using the ultracentrifugation method.
Time Frame Baseline and Weeks 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part B full analysis set
Arm/Group Title Part B: Placebo Part B: Evolocumab
Hide Arm/Group Description:
Participants received double-blind placebo subcutaneously once a month for 12 weeks.
Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
Overall Number of Participants Analyzed 16 33
Least Squares Mean (Standard Error)
Unit of Measure: percent change
4.22  (4.56) -25.56  (3.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -29.78
Confidence Interval (2-Sided) 95%
-40.94 to -18.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.54
Estimation Comments Placebo is the reference
11.Secondary Outcome
Title Part B: Percent Change From Baseline in Apolipoprotein B at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part B full analysis set
Arm/Group Title Part B: Placebo Part B: Evolocumab
Hide Arm/Group Description:
Participants received double-blind placebo subcutaneously once a month for 12 weeks.
Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
Overall Number of Participants Analyzed 16 33
Least Squares Mean (Standard Error)
Unit of Measure: percent change
3.97  (4.74) -19.17  (3.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -23.14
Confidence Interval (2-Sided) 95%
-34.83 to -11.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.81
Estimation Comments Placebo is the reference
12.Secondary Outcome
Title Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12
Hide Description [Not Specified]
Time Frame Baseline and Weeks 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part B full analysis set
Arm/Group Title Part B: Placebo Part B: Evolocumab
Hide Arm/Group Description:
Participants received double-blind placebo subcutaneously once a month for 12 weeks.
Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
Overall Number of Participants Analyzed 16 33
Least Squares Mean (Standard Error)
Unit of Measure: percent change
2.65  (4.42) -20.24  (3.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -22.89
Confidence Interval (2-Sided) 95%
-33.72 to -12.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.38
Estimation Comments Placebo is the reference
13.Secondary Outcome
Title Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part B full anlaysis set
Arm/Group Title Part B: Placebo Part B: Evolocumab
Hide Arm/Group Description:
Participants received double-blind placebo subcutaneously once a month for 12 weeks.
Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
Overall Number of Participants Analyzed 16 33
Least Squares Mean (Standard Error)
Unit of Measure: percent change
2.43  (5.49) -9.40  (4.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -11.83
Confidence Interval (2-Sided) 95%
-25.48 to 1.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.77
Estimation Comments Placebo is the reference
14.Secondary Outcome
Title Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12
Hide Description [Not Specified]
Time Frame Baseline and Weeks 6 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part B full analysis set
Arm/Group Title Part B: Placebo Part B: Evolocumab
Hide Arm/Group Description:
Participants received double-blind placebo subcutaneously once a month for 12 weeks.
Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
Overall Number of Participants Analyzed 16 33
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-1.43  (4.78) -12.71  (3.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B: Placebo, Part B: Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects
Comments Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -11.27
Confidence Interval (2-Sided) 95%
-23.11 to 0.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.86
Estimation Comments Placebo is the reference
Time Frame 12 weeks
Adverse Event Reporting Description

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

MedDRA 16.0 was used to code adverse events in Part A; MedDRA 16.1 was used to code adverse events in Part B.

 
Arm/Group Title Part A: OL Evolocumab Part B: DB Placebo Part B: DB Evolocumab
Hide Arm/Group Description Participants received open-label (OL) evolocumab 420 mg subcutaneously once a month for 12 weeks. Participants received double-blind (DB) placebo subcutaneously once a month for 12 weeks. Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
All-Cause Mortality
Part A: OL Evolocumab Part B: DB Placebo Part B: DB Evolocumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Part A: OL Evolocumab Part B: DB Placebo Part B: DB Evolocumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/16 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: OL Evolocumab Part B: DB Placebo Part B: DB Evolocumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/8 (50.00%)   10/16 (62.50%)   11/33 (33.33%) 
Cardiac disorders       
Palpitations  1  0/8 (0.00%)  1/16 (6.25%)  0/33 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/8 (0.00%)  1/16 (6.25%)  1/33 (3.03%) 
Abdominal pain upper  1  0/8 (0.00%)  1/16 (6.25%)  0/33 (0.00%) 
Dyspepsia  1  1/8 (12.50%)  0/16 (0.00%)  0/33 (0.00%) 
Nausea  1  0/8 (0.00%)  2/16 (12.50%)  0/33 (0.00%) 
General disorders       
Chest pain  1  0/8 (0.00%)  1/16 (6.25%)  1/33 (3.03%) 
Fatigue  1  0/8 (0.00%)  1/16 (6.25%)  0/33 (0.00%) 
Injection site pain  1  0/8 (0.00%)  1/16 (6.25%)  0/33 (0.00%) 
Medical device site reaction  1  0/8 (0.00%)  1/16 (6.25%)  0/33 (0.00%) 
Pain  1  1/8 (12.50%)  0/16 (0.00%)  0/33 (0.00%) 
Infections and infestations       
Bronchitis  1  1/8 (12.50%)  0/16 (0.00%)  0/33 (0.00%) 
Gastroenteritis  1  0/8 (0.00%)  0/16 (0.00%)  2/33 (6.06%) 
Influenza  1  0/8 (0.00%)  0/16 (0.00%)  3/33 (9.09%) 
Nasopharyngitis  1  0/8 (0.00%)  0/16 (0.00%)  2/33 (6.06%) 
Upper respiratory tract infection  1  0/8 (0.00%)  1/16 (6.25%)  3/33 (9.09%) 
Investigations       
Blood creatine phosphokinase increased  1  0/8 (0.00%)  1/16 (6.25%)  0/33 (0.00%) 
Weight decreased  1  0/8 (0.00%)  1/16 (6.25%)  0/33 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/8 (0.00%)  1/16 (6.25%)  0/33 (0.00%) 
Nervous system disorders       
Dizziness  1  0/8 (0.00%)  1/16 (6.25%)  0/33 (0.00%) 
Headache  1  0/8 (0.00%)  1/16 (6.25%)  0/33 (0.00%) 
Presyncope  1  0/8 (0.00%)  1/16 (6.25%)  0/33 (0.00%) 
Reproductive system and breast disorders       
Dysmenorrhoea  1  0/8 (0.00%)  1/16 (6.25%)  1/33 (3.03%) 
Respiratory, thoracic and mediastinal disorders       
Rhinitis allergic  1  1/8 (12.50%)  0/16 (0.00%)  0/33 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0/16.1
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.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01588496     History of Changes
Other Study ID Numbers: 20110233
2011-005399-40 ( EudraCT Number )
First Submitted: February 27, 2012
First Posted: May 1, 2012
Results First Submitted: August 28, 2015
Results First Posted: October 2, 2015
Last Update Posted: November 29, 2018