Trial Outcomes & Findings for LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy (NCT NCT01380730)

NCT ID: NCT01380730

Last Updated: 2022-11-15

Results Overview

LDL-C was measured using ultracentrifugation.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 631 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2022-11-15

Participant Flow

This study enrolled adults aged 18 - 80 years who were on a statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, and fasting low-density lipoprotein cholesterol (LDL-C) ≥ 85 mg/dL. The first patient enrolled on 18 July 2011 and the last patient enrolled on 22 December 2011.

Eligible participants were randomized equally into 1 of 8 treatment groups. Randomization was stratified by screening LDL-C level (< 130 mg/dL or ≥ 130 mg/dL) and ezetimibe use at baseline (yes or no).

Participant milestones

Measure	Placebo Q2W Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.	Placebo Q4W Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.	Evolocumab 70 mg Q2W Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 105 mg Q2W Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 140 mg Q2W Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 280 mg Q4W Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 350 mg Q4W Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 420 mg Q4W Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Overall Study STARTED	78	79	79	79	78	79	79	80
Overall Study Received Treatment	78	77	79	79	78	79	79	80
Overall Study COMPLETED	78	79	79	79	77	79	79	80
Overall Study NOT COMPLETED	0	0	0	0	1	0	0	0

Reasons for withdrawal

Measure	Placebo Q2W Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.	Placebo Q4W Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.	Evolocumab 70 mg Q2W Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 105 mg Q2W Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 140 mg Q2W Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 280 mg Q4W Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 350 mg Q4W Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 420 mg Q4W Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Overall Study Death	0	0	0	0	1	0	0	0

Baseline Characteristics

LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

Baseline characteristics by cohort

Measure	Placebo Q2W n=78 Participants Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.	Placebo Q4W n=77 Participants Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.	Evolocumab 70 mg Q2W n=79 Participants Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 105 mg Q2W n=79 Participants Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 140 mg Q2W n=78 Participants Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 280 mg Q4W n=79 Participants Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 350 mg Q4W n=79 Participants Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 420 mg Q4W n=80 Participants Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Total n=629 Participants Total of all reporting groups
Age, Continuous	60.2 years STANDARD_DEVIATION 8.8 • n=93 Participants	60.1 years STANDARD_DEVIATION 9.6 • n=4 Participants	59.4 years STANDARD_DEVIATION 9.9 • n=27 Participants	58.8 years STANDARD_DEVIATION 9.7 • n=483 Participants	62.4 years STANDARD_DEVIATION 10.2 • n=36 Participants	60.3 years STANDARD_DEVIATION 8.4 • n=10 Participants	61.9 years STANDARD_DEVIATION 8.8 • n=115 Participants	60.9 years STANDARD_DEVIATION 10.3 • n=40 Participants	60.5 years STANDARD_DEVIATION 9.5 • n=8 Participants
Sex: Female, Male Female	42 Participants n=93 Participants	41 Participants n=4 Participants	44 Participants n=27 Participants	25 Participants n=483 Participants	45 Participants n=36 Participants	40 Participants n=10 Participants	38 Participants n=115 Participants	44 Participants n=40 Participants	319 Participants n=8 Participants
Sex: Female, Male Male	36 Participants n=93 Participants	36 Participants n=4 Participants	35 Participants n=27 Participants	54 Participants n=483 Participants	33 Participants n=36 Participants	39 Participants n=10 Participants	41 Participants n=115 Participants	36 Participants n=40 Participants	310 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=93 Participants	1 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	1 participants n=36 Participants	1 participants n=10 Participants	0 participants n=115 Participants	0 participants n=40 Participants	3 participants n=8 Participants
Race/Ethnicity, Customized Asian	0 participants n=93 Participants	2 participants n=4 Participants	1 participants n=27 Participants	3 participants n=483 Participants	1 participants n=36 Participants	2 participants n=10 Participants	2 participants n=115 Participants	1 participants n=40 Participants	12 participants n=8 Participants
Race/Ethnicity, Customized Black or African American	6 participants n=93 Participants	0 participants n=4 Participants	6 participants n=27 Participants	8 participants n=483 Participants	9 participants n=36 Participants	8 participants n=10 Participants	4 participants n=115 Participants	9 participants n=40 Participants	50 participants n=8 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	1 participants n=483 Participants	0 participants n=36 Participants	2 participants n=10 Participants	0 participants n=115 Participants	0 participants n=40 Participants	3 participants n=8 Participants
Race/Ethnicity, Customized White	72 participants n=93 Participants	74 participants n=4 Participants	72 participants n=27 Participants	67 participants n=483 Participants	67 participants n=36 Participants	64 participants n=10 Participants	72 participants n=115 Participants	70 participants n=40 Participants	558 participants n=8 Participants
Race/Ethnicity, Customized Other	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	0 participants n=36 Participants	2 participants n=10 Participants	1 participants n=115 Participants	0 participants n=40 Participants	3 participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 participants n=93 Participants	6 participants n=4 Participants	5 participants n=27 Participants	0 participants n=483 Participants	6 participants n=36 Participants	1 participants n=10 Participants	0 participants n=115 Participants	2 participants n=40 Participants	21 participants n=8 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	77 participants n=93 Participants	71 participants n=4 Participants	74 participants n=27 Participants	79 participants n=483 Participants	72 participants n=36 Participants	78 participants n=10 Participants	79 participants n=115 Participants	78 participants n=40 Participants	608 participants n=8 Participants
Stratification Factor: LDL-C Level < 130 mg/dL	51 participants n=93 Participants	51 participants n=4 Participants	51 participants n=27 Participants	51 participants n=483 Participants	52 participants n=36 Participants	51 participants n=10 Participants	52 participants n=115 Participants	53 participants n=40 Participants	412 participants n=8 Participants
Stratification Factor: LDL-C Level ≥ 130 mg/dL	27 participants n=93 Participants	26 participants n=4 Participants	28 participants n=27 Participants	28 participants n=483 Participants	26 participants n=36 Participants	28 participants n=10 Participants	27 participants n=115 Participants	27 participants n=40 Participants	217 participants n=8 Participants
Stratification Factor: Baseline Ezetimibe Use No	71 participants n=93 Participants	69 participants n=4 Participants	72 participants n=27 Participants	72 participants n=483 Participants	71 participants n=36 Participants	72 participants n=10 Participants	72 participants n=115 Participants	73 participants n=40 Participants	572 participants n=8 Participants
Stratification Factor: Baseline Ezetimibe Use Yes	7 participants n=93 Participants	8 participants n=4 Participants	7 participants n=27 Participants	7 participants n=483 Participants	7 participants n=36 Participants	7 participants n=10 Participants	7 participants n=115 Participants	7 participants n=40 Participants	57 participants n=8 Participants
LDL-C Concentration	122.2 mg/dL STANDARD_DEVIATION 27.1 • n=93 Participants	124.9 mg/dL STANDARD_DEVIATION 30.6 • n=4 Participants	121.4 mg/dL STANDARD_DEVIATION 24.4 • n=27 Participants	127.4 mg/dL STANDARD_DEVIATION 32.1 • n=483 Participants	120.9 mg/dL STANDARD_DEVIATION 25.1 • n=36 Participants	122.0 mg/dL STANDARD_DEVIATION 28.8 • n=10 Participants	123.2 mg/dL STANDARD_DEVIATION 27.1 • n=115 Participants	120.8 mg/dL STANDARD_DEVIATION 26.5 • n=40 Participants	122.8 mg/dL STANDARD_DEVIATION 27.7 • n=8 Participants
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration	146.9 mg/dL STANDARD_DEVIATION 29.9 • n=93 Participants	150.2 mg/dL STANDARD_DEVIATION 36.5 • n=4 Participants	145.3 mg/dL STANDARD_DEVIATION 29.9 • n=27 Participants	151.2 mg/dL STANDARD_DEVIATION 37.2 • n=483 Participants	145.3 mg/dL STANDARD_DEVIATION 26.2 • n=36 Participants	146.3 mg/dL STANDARD_DEVIATION 33.3 • n=10 Participants	150.0 mg/dL STANDARD_DEVIATION 29.1 • n=115 Participants	144.4 mg/dL STANDARD_DEVIATION 31.2 • n=40 Participants	147.4 mg/dL STANDARD_DEVIATION 31.8 • n=8 Participants
Apolipoprotein B Concentration	99.9 mg/dL STANDARD_DEVIATION 17.0 • n=93 Participants	101.6 mg/dL STANDARD_DEVIATION 20.0 • n=4 Participants	99.9 mg/dL STANDARD_DEVIATION 16.8 • n=27 Participants	103.6 mg/dL STANDARD_DEVIATION 22.3 • n=483 Participants	98.8 mg/dL STANDARD_DEVIATION 16.6 • n=36 Participants	101.3 mg/dL STANDARD_DEVIATION 21.2 • n=10 Participants	102.6 mg/dL STANDARD_DEVIATION 18.9 • n=115 Participants	99.9 mg/dL STANDARD_DEVIATION 18.6 • n=40 Participants	100.9 mg/dL STANDARD_DEVIATION 19.0 • n=8 Participants
Total Cholesterol/HDL-C ratio	3.940 ratio STANDARD_DEVIATION 1.016 • n=93 Participants	4.057 ratio STANDARD_DEVIATION 1.303 • n=4 Participants	4.002 ratio STANDARD_DEVIATION 1.243 • n=27 Participants	4.128 ratio STANDARD_DEVIATION 1.473 • n=483 Participants	3.932 ratio STANDARD_DEVIATION 1.022 • n=36 Participants	4.007 ratio STANDARD_DEVIATION 1.300 • n=10 Participants	4.118 ratio STANDARD_DEVIATION 0.963 • n=115 Participants	3.885 ratio STANDARD_DEVIATION 1.090 • n=40 Participants	4.008 ratio STANDARD_DEVIATION 1.184 • n=8 Participants
Apolipoprotein B/Apolipoprotein A-1 Ratio	0.660 ratio STANDARD_DEVIATION 0.155 • n=93 Participants	0.676 ratio STANDARD_DEVIATION 0.194 • n=4 Participants	0.675 ratio STANDARD_DEVIATION 0.191 • n=27 Participants	0.695 ratio STANDARD_DEVIATION 0.219 • n=483 Participants	0.649 ratio STANDARD_DEVIATION 0.155 • n=36 Participants	0.662 ratio STANDARD_DEVIATION 0.199 • n=10 Participants	0.687 ratio STANDARD_DEVIATION 0.175 • n=115 Participants	0.653 ratio STANDARD_DEVIATION 0.177 • n=40 Participants	0.670 ratio STANDARD_DEVIATION 0.184 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; missing ultracentrifugation LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.

LDL-C was measured using ultracentrifugation.

Outcome measures

Measure	Placebo Q2W n=78 Participants Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.	Placebo Q4W n=77 Participants Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.	Evolocumab 70 mg Q2W n=79 Participants Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 105 mg Q2W n=79 Participants Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 140 mg Q2W n=78 Participants Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 280 mg Q4W n=79 Participants Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 350 mg Q4W n=79 Participants Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 420 mg Q4W n=80 Participants Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12	2.76 percent change Standard Error 2.39	-0.98 percent change Standard Error 2.51	-39.06 percent change Standard Error 2.39	-57.48 percent change Standard Error 2.39	-63.34 percent change Standard Error 2.40	-42.82 percent change Standard Error 2.52	-50.98 percent change Standard Error 2.51	-51.31 percent change Standard Error 2.53

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; missing data at Week 12 were imputed using LOCF.

LDL-C was measured using ultracentrifugation.

Outcome measures

Measure	Placebo Q2W n=78 Participants Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.	Placebo Q4W n=77 Participants Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.	Evolocumab 70 mg Q2W n=79 Participants Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 105 mg Q2W n=79 Participants Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 140 mg Q2W n=78 Participants Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 280 mg Q4W n=79 Participants Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 350 mg Q4W n=79 Participants Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 420 mg Q4W n=80 Participants Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Change From Baseline in LDL-C at Week 12	-0.2 mg/dL Standard Error 3.4	-3.2 mg/dL Standard Error 3.3	-50.9 mg/dL Standard Error 3.4	-77.6 mg/dL Standard Error 3.5	-79.5 mg/dL Standard Error 3.4	-53.7 mg/dL Standard Error 3.3	-64.3 mg/dL Standard Error 3.3	-64.3 mg/dL Standard Error 3.3

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; missing data at Week 12 were imputed using LOCF.

Outcome measures

Measure	Placebo Q2W n=78 Participants Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.	Placebo Q4W n=77 Participants Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.	Evolocumab 70 mg Q2W n=79 Participants Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 105 mg Q2W n=79 Participants Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 140 mg Q2W n=78 Participants Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 280 mg Q4W n=79 Participants Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 350 mg Q4W n=79 Participants Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 420 mg Q4W n=80 Participants Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12	2.21 percent change Standard Error 2.20	-1.26 percent change Standard Error 2.26	-36.23 percent change Standard Error 2.20	-53.21 percent change Standard Error 2.20	-59.19 percent change Standard Error 2.21	-39.05 percent change Standard Error 2.27	-47.05 percent change Standard Error 2.26	-48.83 percent change Standard Error 2.27

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; missing data at Week 12 were imputed using LOCF.

Outcome measures

Measure	Placebo Q2W n=78 Participants Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.	Placebo Q4W n=77 Participants Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.	Evolocumab 70 mg Q2W n=79 Participants Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 105 mg Q2W n=79 Participants Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 140 mg Q2W n=78 Participants Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 280 mg Q4W n=79 Participants Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 350 mg Q4W n=79 Participants Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 420 mg Q4W n=80 Participants Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Percent Change From Baseline in Apolipoprotein B at Week 12	5.86 percent change Standard Error 2.15	3.22 percent change Standard Error 2.25	-28.88 percent change Standard Error 2.15	-44.29 percent change Standard Error 2.14	-50.59 percent change Standard Error 2.15	-31.16 percent change Standard Error 2.26	-37.55 percent change Standard Error 2.26	-38.81 percent change Standard Error 2.27

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; missing data at Week 12 were imputed using LOCF.

Outcome measures

Measure	Placebo Q2W n=78 Participants Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.	Placebo Q4W n=77 Participants Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.	Evolocumab 70 mg Q2W n=79 Participants Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 105 mg Q2W n=79 Participants Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 140 mg Q2W n=78 Participants Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 280 mg Q4W n=79 Participants Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 350 mg Q4W n=79 Participants Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 420 mg Q4W n=80 Participants Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12	2.64 percent change Standard Error 1.97	-2.00 percent change Standard Error 1.90	-28.76 percent change Standard Error 1.97	-40.73 percent change Standard Error 1.97	-45.09 percent change Standard Error 1.98	-29.73 percent change Standard Error 1.91	-37.97 percent change Standard Error 1.91	-37.66 percent change Standard Error 1.92

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full analysis set; missing data at Week 12 were imputed using LOCF.

Outcome measures

Measure	Placebo Q2W n=78 Participants Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.	Placebo Q4W n=77 Participants Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.	Evolocumab 70 mg Q2W n=79 Participants Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 105 mg Q2W n=79 Participants Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 140 mg Q2W n=78 Participants Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 280 mg Q4W n=79 Participants Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 350 mg Q4W n=79 Participants Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 420 mg Q4W n=80 Participants Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12	-0.30 percent change Standard Error 2.13	-0.35 percent change Standard Error 2.38	-35.04 percent change Standard Error 2.13	-47.60 percent change Standard Error 2.12	-53.73 percent change Standard Error 2.14	-34.11 percent change Standard Error 2.40	-42.74 percent change Standard Error 2.39	-43.28 percent change Standard Error 2.40

Adverse Events

Placebo Q2W

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo Q4W

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Evolocumab 70 mg Q2W

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Evolocumab 105 mg Q2W

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Evolocumab 140 mg Q2W

Serious events: 4 serious events

Other events: 27 other events

Deaths: 0 deaths

Evolocumab 280 mg Q4W

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Evolocumab 350 mg Q4W

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Evolocumab 420 mg Q4W

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Q2W n=78 participants at risk Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.	Placebo Q4W n=77 participants at risk Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.	Evolocumab 70 mg Q2W n=79 participants at risk Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 105 mg Q2W n=79 participants at risk Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 140 mg Q2W n=78 participants at risk Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 280 mg Q4W n=79 participants at risk Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 350 mg Q4W n=79 participants at risk Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 420 mg Q4W n=80 participants at risk Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Psychiatric disorders Delirium	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Substance abuse	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Penile haemorrhage	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.2% 1/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial fibrillation	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure congestive	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery disease	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tachycardia	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pain	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis acute	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Laceration	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.2% 1/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Neurological symptom	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Syncope	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Social circumstances Physical assault	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Coronary artery bypass	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Measure	Placebo Q2W n=78 participants at risk Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.	Placebo Q4W n=77 participants at risk Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.	Evolocumab 70 mg Q2W n=79 participants at risk Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 105 mg Q2W n=79 participants at risk Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 140 mg Q2W n=78 participants at risk Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.	Evolocumab 280 mg Q4W n=79 participants at risk Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 350 mg Q4W n=79 participants at risk Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.	Evolocumab 420 mg Q4W n=80 participants at risk Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Gastrointestinal disorders Diarrhoea	2.6% 2/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 2/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 4/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 2/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.5% 2/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 3/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 3/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 4/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 3/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 4/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.5% 2/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.2% 5/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Influenza	2.6% 2/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 3/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 3/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.7% 6/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Nasopharyngitis	7.7% 6/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.5% 5/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 9/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.1% 8/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.0% 7/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.1% 8/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.1% 8/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.0% 8/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	2.6% 2/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 2/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.5% 2/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 3/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 4/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 4/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.9% 3/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 4/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.3% 5/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 2/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.2% 1/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.5% 2/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 2/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 4/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 3/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 3/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 2/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.5% 2/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 4/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 4/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.2% 1/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	2.6% 2/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.1% 4/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.5% 2/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.5% 2/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Cough	1.3% 1/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.6% 2/77 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 3/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 3/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/78 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.6% 6/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 1/79 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 3/80 • 12 weeks Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER