Trial Outcomes & Findings for Imaging of Coronary Plaques in Participants Treated With Evolocumab (NCT NCT03570697)
NCT ID: NCT03570697
Last Updated: 2022-05-03
Results Overview
Absolute change from baseline in minimum FCT in a matched segment of artery as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
164 participants
Primary outcome timeframe
Baseline, week 50
Results posted on
2022-05-03
Participant Flow
Participants were enrolled at 23 research centers in Australia (2), Czech Republic (2), Germany (2), Hungary (4), Italy (6), and the Netherlands (7), from November 2018 to December 2019.
Participants were randomized 1:1 into 2 treatment groups: evolocumab 420 mg subcutaneously (SC) monthly (QM) or placebo SC QM. Randomization was stratified by current statin use (\> 4 weeks or ≤ 4 weeks) at screening.
Participant milestones
| Measure |
Placebo
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
81
|
80
|
|
Overall Study
COMPLETED
|
76
|
79
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
Full Analysis Set: all participants who received at least 1 dose of study drug.
Baseline characteristics by cohort
| Measure |
Placebo
n=82 Participants
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
n=82 Participants
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 9.4 • n=82 Participants
|
61.1 years
STANDARD_DEVIATION 10.0 • n=82 Participants
|
60.8 years
STANDARD_DEVIATION 9.6 • n=164 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=82 Participants
|
20 Participants
n=82 Participants
|
46 Participants
n=164 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=82 Participants
|
62 Participants
n=82 Participants
|
118 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=82 Participants
|
4 Participants
n=82 Participants
|
5 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=82 Participants
|
78 Participants
n=82 Participants
|
159 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=82 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=164 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=82 Participants
|
1 Participants
n=82 Participants
|
2 Participants
n=164 Participants
|
|
Race/Ethnicity, Customized
White
|
80 Participants
n=82 Participants
|
79 Participants
n=82 Participants
|
159 Participants
n=164 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
1 Participants
n=82 Participants
|
2 Participants
n=82 Participants
|
3 Participants
n=164 Participants
|
|
Stratification Factor: Statin Use at Screening
> 4 weeks of statin use
|
20 Participants
n=82 Participants
|
19 Participants
n=82 Participants
|
39 Participants
n=164 Participants
|
|
Stratification Factor: Statin Use at Screening
≤ 4 weeks of statin use
|
62 Participants
n=82 Participants
|
63 Participants
n=82 Participants
|
125 Participants
n=164 Participants
|
|
Minimum Fibrous Cap Thickness (FCT)
|
54.6 µm
STANDARD_DEVIATION 15.1 • n=81 Participants • Full Analysis Set: all participants who received at least 1 dose of study drug.
|
56.6 µm
STANDARD_DEVIATION 17.8 • n=80 Participants • Full Analysis Set: all participants who received at least 1 dose of study drug.
|
55.6 µm
STANDARD_DEVIATION 16.5 • n=161 Participants • Full Analysis Set: all participants who received at least 1 dose of study drug.
|
PRIMARY outcome
Timeframe: Baseline, week 50Population: Full Analysis Set: all participants who received at least 1 dose of study drug.
Absolute change from baseline in minimum FCT in a matched segment of artery as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation.
Outcome measures
| Measure |
Placebo
n=81 Participants
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
n=80 Participants
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
|---|---|---|
|
Absolute Change From Baseline in Minimum FCT
|
21.5 µm
Standard Error 5.2
|
42.7 µm
Standard Error 5.1
|
SECONDARY outcome
Timeframe: Baseline, week 50Population: Full Analysis Set: all participants who received at least 1 dose of study drug.
Percent change from baseline in minimum FCT in a matched segment of artery as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation.
Outcome measures
| Measure |
Placebo
n=81 Participants
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
n=80 Participants
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
|---|---|---|
|
Percent Change From Baseline in Minimum FCT
|
44.30 percent change
Standard Error 11.76
|
81.76 percent change
Standard Error 10.94
|
SECONDARY outcome
Timeframe: Baseline, week 50Population: Full Analysis Set: all participants who received at least 1 dose of study drug.
Absolute change from baseline in mean minimum FCT for all images assessed in an individual participant as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation.
Outcome measures
| Measure |
Placebo
n=81 Participants
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
n=80 Participants
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
|---|---|---|
|
Absolute Change From Baseline in Mean Minimum FCT
|
29.78 µm
Standard Error 6.88
|
62.29 µm
Standard Error 5.95
|
SECONDARY outcome
Timeframe: Baseline, week 50Population: Full Analysis Set: all participants who received at least 1 dose of study drug.
Absolute change from baseline in the maximum lipid arc in a matched segment of artery as determined by OCT. Lower value of lipid arc indicates a better situation.
Outcome measures
| Measure |
Placebo
n=81 Participants
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
n=80 Participants
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
|---|---|---|
|
Absolute Change From Baseline in the Maximum Lipid Arc
|
-31.4 degrees
Standard Error 9.0
|
-57.5 degrees
Standard Error 7.4
|
SECONDARY outcome
Timeframe: Baseline, week 50Population: Full Analysis Set: all participants who received at least 1 dose of study drug.
Absolute change from baseline in minimum FCT in lipid rich plaques as determined by OCT. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Higher value of FCT indicates a better situation
Outcome measures
| Measure |
Placebo
n=81 Participants
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
n=80 Participants
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
|---|---|---|
|
Absolute Change From Baseline in Minimum FCT in Lipid Rich Plaques
|
24.6 μm
Standard Error 5.5
|
40.6 μm
Standard Error 5.5
|
SECONDARY outcome
Timeframe: Baseline, week 50Population: Full Analysis Set: all participants who received at least 1 dose of study drug.
Absolute change from baseline in maximum lipid arc in lipid rich plaques. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Lower value of lipid arc indicates a better situation.
Outcome measures
| Measure |
Placebo
n=81 Participants
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
n=80 Participants
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
|---|---|---|
|
Absolute Change From Baseline in Maximum Lipid Arc in Lipid Rich Plaques
|
-31.9 degrees
Standard Error 8.1
|
-61.9 degrees
Standard Error 7.9
|
SECONDARY outcome
Timeframe: Baseline, week 50Population: Full Analysis Set: all participants who received at least 1 dose of study drug.
Absolute change from baseline in lipid core length in lipid rich plaques. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Lower value of lipid core length indicates a better situation.
Outcome measures
| Measure |
Placebo
n=81 Participants
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
n=80 Participants
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
|---|---|---|
|
Absolute Change From Baseline in Lipid Core Length in Lipid Rich Plaques
|
-3.33 mm
Standard Error 0.64
|
-5.76 mm
Standard Error 0.61
|
Adverse Events
Placebo
Serious events: 16 serious events
Other events: 30 other events
Deaths: 2 deaths
Evolocumab
Serious events: 13 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=81 participants at risk
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
n=80 participants at risk
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
|---|---|---|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Cardiac disorders
Acute myocardial infarction
|
3.7%
3/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Cardiac disorders
Angina unstable
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
General disorders
Chest pain
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Infections and infestations
Meningitis staphylococcal
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Nervous system disorders
Syncope
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertensive crisis
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
Other adverse events
| Measure |
Placebo
n=81 participants at risk
Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
Evolocumab
n=80 participants at risk
Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
8.6%
7/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
5.0%
4/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
2.5%
2/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
2.5%
2/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
4/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
3.8%
3/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
General disorders
Fatigue
|
2.5%
2/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
3.8%
3/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
2.5%
2/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Infections and infestations
Influenza
|
2.5%
2/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
2.5%
2/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
2.5%
2/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
2.5%
2/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
2.5%
2/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.7%
3/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
6/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
6.2%
5/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Nervous system disorders
Headache
|
2.5%
2/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
3/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
2.5%
2/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
3.8%
3/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
2/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
2.5%
2/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
2.5%
2/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.5%
2/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
0.00%
0/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
2/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
1.2%
1/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Vascular disorders
Hypertension
|
6.2%
5/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
7.5%
6/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
|
Vascular disorders
Hypotension
|
1.2%
1/81 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
3.8%
3/80 • All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized.
|
Additional Information
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