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Trial Outcomes & Findings for Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C) (NCT NCT02597127)

NCT ID: NCT02597127

Last Updated: 2019-05-17

Results Overview

Percent Change in LDL-C (beta-quantification) from Baseline to Day 180 in MITT Population

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

501 participants

Primary outcome timeframe

Baseline to 180 days

Results posted on

2019-05-17

Participant Flow

Participant milestones

Participant milestones
Measure
Inclisiran 200 mg (Single-dose)
200 mg subcutaneous administration once at Day 1
Inclisiran 300 mg (Single-dose)
300 mg subcutaneous administration once at Day 1
Inclisiran 500 mg (Single-dose)
500 mg subcutaneous administration once at Day 1
Placebo (Single-dose)
Saline subcutaneous administration once at Day 1
Inclisiran 100 mg (Double-dose)
100 mg subcutaneous administration at Day 1 and Day 90
Inclisiran 200 mg (Double-dose)
200 mg subcutaneous administration at Day 1 and Day 90
Inclisiran 300 mg (Double-dose)
300 mg subcutaneous administration at Day 1 and Day 90
Placebo (Double-dose)
Saline subcutaneous administration at Day 1 and Day 90
Overall Study
STARTED
60
62
66
65
62
63
61
62
Overall Study
Treated
60
61
65
65
61
62
61
62
Overall Study
COMPLETED
59
59
58
60
57
59
57
60
Overall Study
NOT COMPLETED
1
3
8
5
5
4
4
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo (Single-dose)
n=65 Participants
Saline subcutaneous administration once at Day 1
Inclisiran 200 mg (Single-dose)
n=60 Participants
200 mg subcutaneous administration once at Day 1
Inclisiran 300 mg (Single-dose)
n=62 Participants
300 mg subcutaneous administration once at Day 1
Inclisiran 500 mg (Single-dose)
n=66 Participants
500 mg subcutaneous administration once at Day 1
Placebo (Double-dose)
n=62 Participants
Saline subcutaneous administration at Day 1 and Day 90
Inclisiran 100 mg (Double-dose)
n=62 Participants
100 mg subcutaneous administration at Day 1 and Day 90
Inclisiran 200 mg (Double-dose)
n=63 Participants
200 mg subcutaneous administration at Day 1 and Day 90
Inclisiran 300 mg (Double-dose)
n=61 Participants
300 mg subcutaneous administration at Day 1 and Day 90
Total
n=501 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Age, Categorical
Between 18 and 65 years
40 Participants
n=5 Participants
30 Participants
n=7 Participants
27 Participants
n=5 Participants
32 Participants
n=4 Participants
32 Participants
n=21 Participants
24 Participants
n=10 Participants
37 Participants
n=115 Participants
31 Participants
n=24 Participants
253 Participants
n=42 Participants
Age, Categorical
>=65 years
25 Participants
n=5 Participants
30 Participants
n=7 Participants
35 Participants
n=5 Participants
34 Participants
n=4 Participants
30 Participants
n=21 Participants
38 Participants
n=10 Participants
26 Participants
n=115 Participants
30 Participants
n=24 Participants
248 Participants
n=42 Participants
Age, Continuous
62.0 years
STANDARD_DEVIATION 11.4 • n=5 Participants
63.9 years
STANDARD_DEVIATION 10.8 • n=7 Participants
64.1 years
STANDARD_DEVIATION 12.8 • n=5 Participants
62.1 years
STANDARD_DEVIATION 12.4 • n=4 Participants
62.8 years
STANDARD_DEVIATION 10.3 • n=21 Participants
65.2 years
STANDARD_DEVIATION 9.4 • n=10 Participants
62.3 years
STANDARD_DEVIATION 10.8 • n=115 Participants
64.1 years
STANDARD_DEVIATION 9.4 • n=24 Participants
63.6 years
STANDARD_DEVIATION 10.0 • n=42 Participants
Sex: Female, Male
Female
23 Participants
n=5 Participants
21 Participants
n=7 Participants
20 Participants
n=5 Participants
19 Participants
n=4 Participants
29 Participants
n=21 Participants
23 Participants
n=10 Participants
24 Participants
n=115 Participants
16 Participants
n=24 Participants
175 Participants
n=42 Participants
Sex: Female, Male
Male
42 Participants
n=5 Participants
39 Participants
n=7 Participants
42 Participants
n=5 Participants
47 Participants
n=4 Participants
33 Participants
n=21 Participants
39 Participants
n=10 Participants
39 Participants
n=115 Participants
45 Participants
n=24 Participants
326 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
n=5 Participants
4 Participants
n=7 Participants
3 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
2 Participants
n=10 Participants
6 Participants
n=115 Participants
4 Participants
n=24 Participants
29 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
58 Participants
n=5 Participants
56 Participants
n=7 Participants
59 Participants
n=5 Participants
65 Participants
n=4 Participants
60 Participants
n=21 Participants
60 Participants
n=10 Participants
57 Participants
n=115 Participants
57 Participants
n=24 Participants
472 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
2 Participants
n=10 Participants
0 Participants
n=115 Participants
1 Participants
n=24 Participants
6 Participants
n=42 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
1 Participants
n=10 Participants
0 Participants
n=115 Participants
1 Participants
n=24 Participants
9 Participants
n=42 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
4 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
3 Participants
n=21 Participants
2 Participants
n=10 Participants
2 Participants
n=115 Participants
1 Participants
n=24 Participants
18 Participants
n=42 Participants
Race (NIH/OMB)
White
59 Participants
n=5 Participants
53 Participants
n=7 Participants
56 Participants
n=5 Participants
63 Participants
n=4 Participants
58 Participants
n=21 Participants
57 Participants
n=10 Participants
61 Participants
n=115 Participants
58 Participants
n=24 Participants
465 Participants
n=42 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
2 Participants
n=42 Participants
Region of Enrollment
Canada
8 Participants
n=5 Participants
8 Participants
n=7 Participants
7 Participants
n=5 Participants
12 Participants
n=4 Participants
10 Participants
n=21 Participants
10 Participants
n=10 Participants
7 Participants
n=115 Participants
9 Participants
n=24 Participants
71 Participants
n=42 Participants
Region of Enrollment
Netherlands
22 Participants
n=5 Participants
21 Participants
n=7 Participants
21 Participants
n=5 Participants
21 Participants
n=4 Participants
20 Participants
n=21 Participants
20 Participants
n=10 Participants
23 Participants
n=115 Participants
21 Participants
n=24 Participants
169 Participants
n=42 Participants
Region of Enrollment
United States
12 Participants
n=5 Participants
10 Participants
n=7 Participants
10 Participants
n=5 Participants
12 Participants
n=4 Participants
8 Participants
n=21 Participants
10 Participants
n=10 Participants
12 Participants
n=115 Participants
10 Participants
n=24 Participants
84 Participants
n=42 Participants
Region of Enrollment
United Kingdom
11 Participants
n=5 Participants
11 Participants
n=7 Participants
11 Participants
n=5 Participants
11 Participants
n=4 Participants
10 Participants
n=21 Participants
9 Participants
n=10 Participants
11 Participants
n=115 Participants
12 Participants
n=24 Participants
86 Participants
n=42 Participants
Region of Enrollment
Germany
12 Participants
n=5 Participants
10 Participants
n=7 Participants
13 Participants
n=5 Participants
10 Participants
n=4 Participants
14 Participants
n=21 Participants
13 Participants
n=10 Participants
10 Participants
n=115 Participants
9 Participants
n=24 Participants
91 Participants
n=42 Participants

PRIMARY outcome

Timeframe: Baseline to 180 days

Population: Modified intent-to-treat (MITT) population

Percent Change in LDL-C (beta-quantification) from Baseline to Day 180 in MITT Population

Outcome measures

Outcome measures
Measure
Placebo (Single Dose)
n=64 Participants
Saline via subcutaneous injection - Single Dose on Day 1
200 mg (Single Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
300 mg (Single Dose)
n=60 Participants
300 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
500 mg (Single Dose)
n=60 Participants
500 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
Placebo (Double Dose)
n=61 Participants
Saline via subcutaneous injection - Two Doses: Day 1 and Day 90
100 mg (Double Dose)
n=59 Participants
100 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
200 mg (Double Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
300 mg (Double Dose)
n=59 Participants
300 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
Percentage Change in LDL-C From Baseline to Day 180
2.1 Percent change
Interval -2.9 to 7.2
-27.9 Percent change
Interval -33.1 to -22.7
-38.4 Percent change
Interval -43.6 to -33.2
-41.9 Percent change
Interval -47.2 to -36.7
1.8 Percent change
Interval -2.6 to 6.3
-35.5 Percent change
Interval -40.0 to -31.0
-44.9 Percent change
Interval -49.3 to -40.4
-52.6 Percent change
Interval -57.1 to -48.1

SECONDARY outcome

Timeframe: Baseline to 90 days

Population: In this analysis, the single and double-dose 200mg arms were combined, as were the single and double-dose 300mg arms. The second dose for patients in double-dose arms was given on Day 90. Therefore, up to day 90, those patients in double-dose arms received the same treatment as patients in the single dose arms within the same dose amount.

Percent Change in LDL-C (beta-quantification) from Baseline to Day 90 in MITT Population

Outcome measures

Outcome measures
Measure
Placebo (Single Dose)
n=60 Participants
Saline via subcutaneous injection - Single Dose on Day 1
200 mg (Single Dose)
n=59 Participants
200 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
300 mg (Single Dose)
n=125 Participants
300 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
500 mg (Single Dose)
n=120 Participants
500 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
Placebo (Double Dose)
n=118 Participants
Saline via subcutaneous injection - Two Doses: Day 1 and Day 90
100 mg (Double Dose)
100 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
200 mg (Double Dose)
200 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
300 mg (Double Dose)
300 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
Percentage Change in LDL-C From Baseline to Day 90
-49 Percent change
Interval -53.8 to -44.2
-34.2 Percent change
Interval -39.1 to -29.3
-0.8 Percent change
Interval -4.2 to 2.5
-41.8 Percent change
Interval -45.3 to -38.4
-45.7 Percent change
Interval -49.2 to -42.3
—
—
—

SECONDARY outcome

Timeframe: Baseline, Day 60, Day 120, and Day 210

This outcome measure evaluated the effects of both single- and double-dose inclisiran on LDL-C levels in the mITT population from baseline to Day 60, Day 120, and Day 210.

Outcome measures

Outcome measures
Measure
Placebo (Single Dose)
n=64 Participants
Saline via subcutaneous injection - Single Dose on Day 1
200 mg (Single Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
300 mg (Single Dose)
n=60 Participants
300 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
500 mg (Single Dose)
n=60 Participants
500 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
Placebo (Double Dose)
n=61 Participants
Saline via subcutaneous injection - Two Doses: Day 1 and Day 90
100 mg (Double Dose)
n=59 Participants
100 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
200 mg (Double Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
300 mg (Double Dose)
n=59 Participants
300 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
Percent Change From Baseline In LDL-C Levels At Day 60, Day 120, and Day 210
Day 60
-4.27 Percent change
Interval -7.84 to -0.7
-44.32 Percent change
Interval -50.55 to -38.09
-50.87 Percent change
Interval -55.62 to -46.12
-49.58 Percent change
Interval -54.12 to -45.04
-1.92 Percent change
Interval -6.7 to 2.85
-35.73 Percent change
Interval -40.23 to -31.23
-44.28 Percent change
Interval -49.1 to -39.47
-50.99 Percent change
Interval -55.51 to -45.67
Percent Change From Baseline In LDL-C Levels At Day 60, Day 120, and Day 210
Day 120
-0.91 Percent change
Interval -5.17 to 3.34
-36.94 Percent change
Interval -42.8 to -31.08
-43.32 Percent change
Interval -48.95 to -37.68
-46.42 Percent change
Interval -50.63 to -42.22
0.17 Percent change
Interval -3.61 to 3.95
-41.37 Percent change
Interval -45.94 to -36.8
-49.54 Percent change
Interval -54.6 to -44.49
-54.73 Percent change
Interval -59.88 to -49.58
Percent Change From Baseline In LDL-C Levels At Day 60, Day 120, and Day 210
Day 210
1.45 Percent change
Interval -3.61 to 6.06
-28.98 Percent change
Interval -36.83 to -21.12
-35.39 Percent change
Interval -41.47 to -29.31
-39.2 Percent change
Interval -43.71 to -34.68
0.58 Percent change
Interval -4.58 to 5.74
-31.67 Percent change
Interval -36.08 to -27.27
-42.59 Percent change
Interval -47.11 to -38.08
-50.54 Percent change
Interval -54.83 to -46.25

SECONDARY outcome

Timeframe: Baseline, Day 180, Day 210

This outcome measure evaluated the number of participants (single and double dose) in the mITT population with an LDL-C greater than 80% of the baseline value at Day 180 and Day 210.

Outcome measures

Outcome measures
Measure
Placebo (Single Dose)
n=64 Participants
Saline via subcutaneous injection - Single Dose on Day 1
200 mg (Single Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
300 mg (Single Dose)
n=60 Participants
300 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
500 mg (Single Dose)
n=60 Participants
500 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
Placebo (Double Dose)
n=61 Participants
Saline via subcutaneous injection - Two Doses: Day 1 and Day 90
100 mg (Double Dose)
n=59 Participants
100 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
200 mg (Double Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
300 mg (Double Dose)
n=59 Participants
300 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
Number of Participants With an LDL-C Greater Than 80% of the Baseline Value at Day 180 and Day 210
Day 210
34 Participants
8 Participants
5 Participants
2 Participants
34 Participants
1 Participants
1 Participants
1 Participants
Number of Participants With an LDL-C Greater Than 80% of the Baseline Value at Day 180 and Day 210
Day 180
35 Participants
6 Participants
5 Participants
0 Participants
29 Participants
2 Participants
1 Participants
0 Participants

SECONDARY outcome

Timeframe: Day 90, Day 180

This outcome measure evaluated the individual responsiveness of participants to inclisiran (single and double dose) in the mITT population as defined by an LDL-C level of \<25 mg/deciliter \[dL\] at Day 90 and Day 180.

Outcome measures

Outcome measures
Measure
Placebo (Single Dose)
n=64 Participants
Saline via subcutaneous injection - Single Dose on Day 1
200 mg (Single Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
300 mg (Single Dose)
n=60 Participants
300 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
500 mg (Single Dose)
n=60 Participants
500 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
Placebo (Double Dose)
n=61 Participants
Saline via subcutaneous injection - Two Doses: Day 1 and Day 90
100 mg (Double Dose)
n=59 Participants
100 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
200 mg (Double Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
300 mg (Double Dose)
n=59 Participants
300 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
Number of Participants With Individual Responsiveness as Measured By LDL-C Levels at Day 90 and Day 180
Day 90
0 Participants
0 Participants
5 Participants
3 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With Individual Responsiveness as Measured By LDL-C Levels at Day 90 and Day 180
Day 180
0 Participants
0 Participants
1 Participants
2 Participants
0 Participants
1 Participants
2 Participants
3 Participants

SECONDARY outcome

Timeframe: Baseline, Day 180

This outcome measure evaluated the number of participants (single and double dose) in the mITT population with an LDL-C reduction greater than 50% of the baseline value at Day 180.

Outcome measures

Outcome measures
Measure
Placebo (Single Dose)
n=64 Participants
Saline via subcutaneous injection - Single Dose on Day 1
200 mg (Single Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
300 mg (Single Dose)
n=60 Participants
300 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
500 mg (Single Dose)
n=60 Participants
500 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
Placebo (Double Dose)
n=61 Participants
Saline via subcutaneous injection - Two Doses: Day 1 and Day 90
100 mg (Double Dose)
n=59 Participants
100 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
200 mg (Double Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
300 mg (Double Dose)
n=59 Participants
300 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
Number of Participants With Greater Or Equal To 50% LDL-C Reduction From Baseline At Day 180
0 Participants
9 Participants
19 Participants
16 Participants
0 Participants
14 Participants
27 Participants
32 Participants

SECONDARY outcome

Timeframe: Baseline, Day 180

This outcome measure evaluated the percent change in proprotein convertase subtilisin/kexin type 9 (PCSK9) from baseline to Day 180 in participants (single and double dose) in the mITT population.

Outcome measures

Outcome measures
Measure
Placebo (Single Dose)
n=64 Participants
Saline via subcutaneous injection - Single Dose on Day 1
200 mg (Single Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
300 mg (Single Dose)
n=60 Participants
300 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
500 mg (Single Dose)
n=60 Participants
500 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
Placebo (Double Dose)
n=61 Participants
Saline via subcutaneous injection - Two Doses: Day 1 and Day 90
100 mg (Double Dose)
n=59 Participants
100 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
200 mg (Double Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
300 mg (Double Dose)
n=59 Participants
300 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
Percentage Change in PCSK9 Levels From Baseline at Day 180
2.2 percent change
Standard Deviation 23.4
-47.9 percent change
Standard Deviation 21
-56 percent change
Standard Deviation 19.2
-59.3 percent change
Standard Deviation 18
-1.2 percent change
Standard Deviation 20.7
-53.2 percent change
Standard Deviation 20.9
-66.2 percent change
Standard Deviation 15.6
-69.1 percent change
Standard Deviation 12.1

SECONDARY outcome

Timeframe: Baseline, Day 180

This outcome measure evaluated the percent change from baseline to Day 180 in cholesterol (total, high-density lipoprotein \[HDL\], non-HDL) and apolipoproteins (B, A1) in participants (single and double dose) in the mITT population.

Outcome measures

Outcome measures
Measure
Placebo (Single Dose)
n=64 Participants
Saline via subcutaneous injection - Single Dose on Day 1
200 mg (Single Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
300 mg (Single Dose)
n=60 Participants
300 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
500 mg (Single Dose)
n=60 Participants
500 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
Placebo (Double Dose)
n=61 Participants
Saline via subcutaneous injection - Two Doses: Day 1 and Day 90
100 mg (Double Dose)
n=59 Participants
100 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
200 mg (Double Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
300 mg (Double Dose)
n=59 Participants
300 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
Percentage Change in Other Lipids and Apolipoproteins From Baseline to Day 180
Apolipoprotein A1
3.6 percent change
Standard Deviation 10.6
2.9 percent change
Standard Deviation 9.3
3.8 percent change
Standard Deviation 8.9
4.1 percent change
Standard Deviation 10.9
0.8 percent change
Standard Deviation 8.3
5.5 percent change
Standard Deviation 10.6
8.6 percent change
Standard Deviation 11.5
6.2 percent change
Standard Deviation 11.9
Percentage Change in Other Lipids and Apolipoproteins From Baseline to Day 180
Total Cholesterol
1.8 percent change
Standard Deviation 12.1
-17.6 percent change
Standard Deviation 19
-23.7 percent change
Standard Deviation 15.7
-26.6 percent change
Standard Deviation 10.7
0.7 percent change
Standard Deviation 12.3
-22.4 percent change
Standard Deviation 12.4
-26.8 percent change
Standard Deviation 13
33.2 percent change
Standard Deviation 11.3
Percentage Change in Other Lipids and Apolipoproteins From Baseline to Day 180
Non-HDL Cholesterol
1.5 percent change
Standard Deviation 16.7
-25.1 percent change
Standard Deviation 26.3
-35.2 percent change
Standard Deviation 20.2
-36.9 percent change
Standard Deviation 14
1.3 percent change
Standard Deviation 16.9
-31.7 percent change
Standard Deviation 15.1
-38.9 percent change
Standard Deviation 16.8
-46 percent change
Standard Deviation 14.6
Percentage Change in Other Lipids and Apolipoproteins From Baseline to Day 180
HDL Cholesterol
3.8 percent change
Standard Deviation 15.6
4.4 percent change
Standard Deviation 14.8
8.8 percent change
Standard Deviation 11.1
6.9 percent change
Standard Deviation 14
0.5 percent change
Standard Deviation 12.5
7.6 percent change
Standard Deviation 12.2
10.3 percent change
Standard Deviation 15.3
8.6 percent change
Standard Deviation 14.9
Percentage Change in Other Lipids and Apolipoproteins From Baseline to Day 180
Apolipoprotein B
1.7 percent change
Standard Deviation 14.7
-22.9 percent change
Standard Deviation 21
-30.8 percent change
Standard Deviation 18
-33.1 percent change
Standard Deviation 12.7
0.9 percent change
Standard Deviation 13
-27.8 percent change
Standard Deviation 13.4
-35 percent change
Standard Deviation 15.8
-40.9 percent change
Standard Deviation 14.8

SECONDARY outcome

Timeframe: Baseline, Day 180

This outcome measure evaluated the proportion of participants (single and double dose) in the mITT population who attained a global lipid modification target by baseline cardiovascular risk group, looking specifically at LDL-C levels (mg/dL) in the category of cardiovascular disease (CVD). CVD was defined as a participant who had at least 1 of the following: prior myocardial infarction, prior percutaneous coronary intervention, prior coronary artery bypass graft, prior stroke, prior transient ischemic attack, peripheral artery disease.

Outcome measures

Outcome measures
Measure
Placebo (Single Dose)
n=64 Participants
Saline via subcutaneous injection - Single Dose on Day 1
200 mg (Single Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
300 mg (Single Dose)
n=60 Participants
300 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
500 mg (Single Dose)
n=60 Participants
500 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
Placebo (Double Dose)
n=61 Participants
Saline via subcutaneous injection - Two Doses: Day 1 and Day 90
100 mg (Double Dose)
n=59 Participants
100 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
200 mg (Double Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
300 mg (Double Dose)
n=59 Participants
300 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
Number of Participants Who Attained Global Lipid Modification Targets for Level of Atherosclerotic Cardiovascular Disease Risk
CVD
45 Participants
43 Participants
46 Participants
33 Participants
45 Participants
41 Participants
39 Participants
42 Participants
Number of Participants Who Attained Global Lipid Modification Targets for Level of Atherosclerotic Cardiovascular Disease Risk
<70 mg/dL
0 Participants
16 Participants
27 Participants
18 Participants
1 Participants
24 Participants
27 Participants
33 Participants

SECONDARY outcome

Timeframe: Baseline, Day 180

This outcome measure evaluated the percent change from baseline to Day 180 in triglycerides, very-low-density lipoprotein (VLDL) cholesterol, lipoprotein(a), and high sensitivity C-reactive protein (hsCRP) in participants (single and double dose) in the mITT population.

Outcome measures

Outcome measures
Measure
Placebo (Single Dose)
n=64 Participants
Saline via subcutaneous injection - Single Dose on Day 1
200 mg (Single Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
300 mg (Single Dose)
n=60 Participants
300 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
500 mg (Single Dose)
n=60 Participants
500 mg Inclisiran via subcutaneous injection - Single Dose on Day 1
Placebo (Double Dose)
n=61 Participants
Saline via subcutaneous injection - Two Doses: Day 1 and Day 90
100 mg (Double Dose)
n=59 Participants
100 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
200 mg (Double Dose)
n=60 Participants
200 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
300 mg (Double Dose)
n=59 Participants
300 mg Inclisiran via subcutaneous injection - Two Doses: Day 1 and Day 90
Percentage Change in Other Lipids and Inflammatory Markers From Baseline to Day 180
VLDL Cholesterol
2.4 percent change
Interval -30.7 to 30.5
-11.6 percent change
Interval -35.8 to 23.3
-23.8 percent change
Interval -43.0 to -6.4
-14.6 percent change
Interval -34.8 to 3.5
2.7 percent change
Interval -20.0 to 26.7
-16.4 percent change
Interval -31.3 to 0.0
-21.2 percent change
Interval -38.5 to 13.2
-16 percent change
Interval -38.2 to 9.1
Percentage Change in Other Lipids and Inflammatory Markers From Baseline to Day 180
hsCRP
-5.3 percent change
Interval -40.8 to 28.4
7.1 percent change
Interval -30.7 to 70.9
-16.2 percent change
Interval -45.8 to 50.0
-19.8 percent change
Interval -50.0 to 32.7
-20 percent change
Interval -50.0 to 30.0
-12.5 percent change
Interval -42.9 to 29.4
-16.3 percent change
Interval -34.6 to 24.3
-16.7 percent change
Interval -50.9 to 33.3
Percentage Change in Other Lipids and Inflammatory Markers From Baseline to Day 180
Triglycerides
6.4 percent change
Interval -15.9 to 21.9
1.1 percent change
Interval -18.5 to 17.8
-12.8 percent change
Interval -27.8 to 7.8
-12.2 percent change
Interval -25.6 to 7.7
-3 percent change
Interval -17.2 to 22.6
-6.3 percent change
Interval -17.6 to 10.9
0.7 percent change
Interval -22.4 to 11.3
-14.2 percent change
Interval -26.4 to 5.4
Percentage Change in Other Lipids and Inflammatory Markers From Baseline to Day 180
Lipoprotein(a)
0.5 percent change
Interval -13.9 to 14.8
-14.3 percent change
Interval -29.5 to -3.5
-14.3 percent change
Interval -25.4 to -5.6
-18.2 percent change
Interval -35.0 to 1.6
0 percent change
Interval -10.0 to 12.4
-14.9 percent change
Interval -26.2 to -1.9
-17.3 percent change
Interval -31.9 to -7.7
-25.6 percent change
Interval -38.5 to -15.2

Adverse Events

Placebo (Single Dose)

Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths

Inclisiran 200 mg (Single Dose)

Serious events: 11 serious events
Other events: 49 other events
Deaths: 0 deaths

Inclisiran 300 mg (Single Dose)

Serious events: 11 serious events
Other events: 49 other events
Deaths: 0 deaths

Inclisiran 500 mg (Single Dose)

Serious events: 8 serious events
Other events: 54 other events
Deaths: 1 deaths

Placebo (Double Dose)

Serious events: 7 serious events
Other events: 51 other events
Deaths: 0 deaths

Inclisiran 100 mg (Double Dose)

Serious events: 13 serious events
Other events: 47 other events
Deaths: 0 deaths

Inclisiran 200 mg (Double Dose)

Serious events: 8 serious events
Other events: 49 other events
Deaths: 1 deaths

Inclisiran 300 mg (Double Dose)

Serious events: 9 serious events
Other events: 51 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo (Single Dose)
n=65 participants at risk
Saline subcutaneous administration once at Day 1
Inclisiran 200 mg (Single Dose)
n=60 participants at risk
200 mg subcutaneous administration once at Day 1
Inclisiran 300 mg (Single Dose)
n=61 participants at risk
300 mg subcutaneous administration once at Day 1
Inclisiran 500 mg (Single Dose)
n=65 participants at risk
500 mg subcutaneous administration once at Day 1
Placebo (Double Dose)
n=62 participants at risk
Saline subcutaneous administration twice at Day 1 and Day 90
Inclisiran 100 mg (Double Dose)
n=61 participants at risk
100 mg subcutaneous administration twice at Day 1 and Day 90
Inclisiran 200 mg (Double Dose)
n=62 participants at risk
200 mg subcutaneous administration twice at Day 1 and Day 90
Inclisiran 300 mg (Double Dose)
n=61 participants at risk
300 mg subcutaneous administration twice at Day 1 and Day 90
Nervous system disorders
Lacunar stroke
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Nervous system disorders
Neuropathy peripheral
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Blood and lymphatic system disorders
Anameia
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Angina pectoris
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Angina unstable
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Atrial flutter
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Acute myocardial infarction
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Atrial fibrillation
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Atrial tachycardia
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Atriventricular block complete
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Cardiac arrest
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Coronary artery disease
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Myocardial infarction
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Pericarditis
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Cardiac disorders
Ventricular extrasystoles
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Aorta-oesophageal fistula
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Constipation
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Gastritis
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Inguinal hernia
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
large instestine polyp
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Proctitis ulcerative
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Volvulus
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Vomiting
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
General disorders
Device dislocation
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
General disorders
Non-cardiac chest pain
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
General disorders
Pain
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
General disorders
Srent-graft endoleak
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
General disorders
Vascular stent restenosis
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Hepatobiliary disorders
Hepatic haemorrhage
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Appendicitis
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Device related infection
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Erysipelas
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Gastroenteritis
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Implant site infection
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Listeria sepsis
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Osteomyelitis
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Urinary tract infection
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Urosepsis
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Wound abcess
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Concussion
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Facial bones fracture
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Humerus fracture
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Intentional overdose
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Ligament sprain
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Limb crushing injury
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Multiple injuries
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Pneumothorax traumatic
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Post procedural complication
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
3.2%
2/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Traumatic haemothorax
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Upperlimb fracture
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Weaning failure
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Investigations
Haemoglobin decreased
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Investigations
Platelet count decreased
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Investigations
Transaminases increased
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Metabolism and nutrition disorders
Dehydration
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Metabolism and nutrition disorders
Hypoglycemia
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Musculoskeletal and connective tissue disorders
Muscle necrosis
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Musculoskeletal and connective tissue disorders
Osteitis
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adeoncarcinoma of colon
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage 0
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage 1
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Nervous system disorders
Carpal tunnel syndrome
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Nervous system disorders
Ischaemic stroke
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Nervous system disorders
Spinal cord ischaemia
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Nervous system disorders
Syncope
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Renal and urinary disorders
Acute kidney injury
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Renal and urinary disorders
Calculus urinary
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Renal and urinary disorders
Stress urinary incontinence
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Vascular disorders
Aortic dissection
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Vascular disorders
Hypotension
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Vascular disorders
Intermittent claudication
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Vascular disorders
Orthostatic hypotension
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360

Other adverse events

Other adverse events
Measure
Placebo (Single Dose)
n=65 participants at risk
Saline subcutaneous administration once at Day 1
Inclisiran 200 mg (Single Dose)
n=60 participants at risk
200 mg subcutaneous administration once at Day 1
Inclisiran 300 mg (Single Dose)
n=61 participants at risk
300 mg subcutaneous administration once at Day 1
Inclisiran 500 mg (Single Dose)
n=65 participants at risk
500 mg subcutaneous administration once at Day 1
Placebo (Double Dose)
n=62 participants at risk
Saline subcutaneous administration twice at Day 1 and Day 90
Inclisiran 100 mg (Double Dose)
n=61 participants at risk
100 mg subcutaneous administration twice at Day 1 and Day 90
Inclisiran 200 mg (Double Dose)
n=62 participants at risk
200 mg subcutaneous administration twice at Day 1 and Day 90
Inclisiran 300 mg (Double Dose)
n=61 participants at risk
300 mg subcutaneous administration twice at Day 1 and Day 90
Cardiac disorders
Angina pectoris
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/60 • Treatment Emergent Adverse Events up to Day 360
6.6%
4/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
3.2%
2/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
3.2%
2/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Abdominal pain
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
5.0%
3/60 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
4.8%
3/62 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
6.6%
4/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Constipation
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
6.7%
4/60 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
3.2%
2/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
3.2%
2/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Diarrhoea
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
6.6%
4/61 • Treatment Emergent Adverse Events up to Day 360
6.2%
4/65 • Treatment Emergent Adverse Events up to Day 360
3.2%
2/62 • Treatment Emergent Adverse Events up to Day 360
4.9%
3/61 • Treatment Emergent Adverse Events up to Day 360
11.3%
7/62 • Treatment Emergent Adverse Events up to Day 360
8.2%
5/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Nausea
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
6.2%
4/65 • Treatment Emergent Adverse Events up to Day 360
4.8%
3/62 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
6.5%
4/62 • Treatment Emergent Adverse Events up to Day 360
4.9%
3/61 • Treatment Emergent Adverse Events up to Day 360
Gastrointestinal disorders
Vomiting
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
6.5%
4/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
General disorders
Fatigue
7.7%
5/65 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/60 • Treatment Emergent Adverse Events up to Day 360
6.6%
4/61 • Treatment Emergent Adverse Events up to Day 360
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
9.7%
6/62 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Gastroenteritis
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
5.0%
3/60 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
3.2%
2/62 • Treatment Emergent Adverse Events up to Day 360
4.9%
3/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Influenza
4.6%
3/65 • Treatment Emergent Adverse Events up to Day 360
5.0%
3/60 • Treatment Emergent Adverse Events up to Day 360
6.6%
4/61 • Treatment Emergent Adverse Events up to Day 360
7.7%
5/65 • Treatment Emergent Adverse Events up to Day 360
3.2%
2/62 • Treatment Emergent Adverse Events up to Day 360
4.9%
3/61 • Treatment Emergent Adverse Events up to Day 360
6.5%
4/62 • Treatment Emergent Adverse Events up to Day 360
8.2%
5/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Nasopharyngitis
6.2%
4/65 • Treatment Emergent Adverse Events up to Day 360
13.3%
8/60 • Treatment Emergent Adverse Events up to Day 360
14.8%
9/61 • Treatment Emergent Adverse Events up to Day 360
13.8%
9/65 • Treatment Emergent Adverse Events up to Day 360
12.9%
8/62 • Treatment Emergent Adverse Events up to Day 360
13.1%
8/61 • Treatment Emergent Adverse Events up to Day 360
8.1%
5/62 • Treatment Emergent Adverse Events up to Day 360
18.0%
11/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Upper respiratory tract infection
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/60 • Treatment Emergent Adverse Events up to Day 360
6.6%
4/61 • Treatment Emergent Adverse Events up to Day 360
7.7%
5/65 • Treatment Emergent Adverse Events up to Day 360
3.2%
2/62 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
4.9%
3/61 • Treatment Emergent Adverse Events up to Day 360
Infections and infestations
Urinary tract infection
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
8.2%
5/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
6.5%
4/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Contusion
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
8.1%
5/62 • Treatment Emergent Adverse Events up to Day 360
4.9%
3/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
Injury, poisoning and procedural complications
Fall
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
6.6%
4/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Investigations
Blood creatine phosphokinase increased
4.6%
3/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
8.1%
5/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
4.8%
3/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Musculoskeletal and connective tissue disorders
Arthralgia
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
6.7%
4/60 • Treatment Emergent Adverse Events up to Day 360
6.6%
4/61 • Treatment Emergent Adverse Events up to Day 360
6.2%
4/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
8.1%
5/62 • Treatment Emergent Adverse Events up to Day 360
4.9%
3/61 • Treatment Emergent Adverse Events up to Day 360
Musculoskeletal and connective tissue disorders
Back pain
7.7%
5/65 • Treatment Emergent Adverse Events up to Day 360
6.7%
4/60 • Treatment Emergent Adverse Events up to Day 360
6.6%
4/61 • Treatment Emergent Adverse Events up to Day 360
6.2%
4/65 • Treatment Emergent Adverse Events up to Day 360
3.2%
2/62 • Treatment Emergent Adverse Events up to Day 360
9.8%
6/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
6.6%
4/61 • Treatment Emergent Adverse Events up to Day 360
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
6.5%
4/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/62 • Treatment Emergent Adverse Events up to Day 360
9.8%
6/61 • Treatment Emergent Adverse Events up to Day 360
Musculoskeletal and connective tissue disorders
Myalgia
4.6%
3/65 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/60 • Treatment Emergent Adverse Events up to Day 360
9.8%
6/61 • Treatment Emergent Adverse Events up to Day 360
4.6%
3/65 • Treatment Emergent Adverse Events up to Day 360
4.8%
3/62 • Treatment Emergent Adverse Events up to Day 360
11.5%
7/61 • Treatment Emergent Adverse Events up to Day 360
8.1%
5/62 • Treatment Emergent Adverse Events up to Day 360
8.2%
5/61 • Treatment Emergent Adverse Events up to Day 360
Musculoskeletal and connective tissue disorders
Pain in extremity
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/60 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
6.5%
4/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
6.5%
4/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
Nervous system disorders
Dizziness
4.6%
3/65 • Treatment Emergent Adverse Events up to Day 360
1.7%
1/60 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
9.7%
6/62 • Treatment Emergent Adverse Events up to Day 360
4.9%
3/61 • Treatment Emergent Adverse Events up to Day 360
4.8%
3/62 • Treatment Emergent Adverse Events up to Day 360
4.9%
3/61 • Treatment Emergent Adverse Events up to Day 360
Nervous system disorders
Headache
9.2%
6/65 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/60 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/61 • Treatment Emergent Adverse Events up to Day 360
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
8.1%
5/62 • Treatment Emergent Adverse Events up to Day 360
8.2%
5/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
8.2%
5/61 • Treatment Emergent Adverse Events up to Day 360
Respiratory, thoracic and mediastinal disorders
Cough
3.1%
2/65 • Treatment Emergent Adverse Events up to Day 360
6.7%
4/60 • Treatment Emergent Adverse Events up to Day 360
11.5%
7/61 • Treatment Emergent Adverse Events up to Day 360
4.6%
3/65 • Treatment Emergent Adverse Events up to Day 360
4.8%
3/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360
9.7%
6/62 • Treatment Emergent Adverse Events up to Day 360
4.9%
3/61 • Treatment Emergent Adverse Events up to Day 360
Respiratory, thoracic and mediastinal disorders
Epistaxis
6.2%
4/65 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/60 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/62 • Treatment Emergent Adverse Events up to Day 360
0.00%
0/61 • Treatment Emergent Adverse Events up to Day 360
Vascular disorders
Hypertension
0.00%
0/65 • Treatment Emergent Adverse Events up to Day 360
3.3%
2/60 • Treatment Emergent Adverse Events up to Day 360
4.9%
3/61 • Treatment Emergent Adverse Events up to Day 360
1.5%
1/65 • Treatment Emergent Adverse Events up to Day 360
4.8%
3/62 • Treatment Emergent Adverse Events up to Day 360
6.6%
4/61 • Treatment Emergent Adverse Events up to Day 360
3.2%
2/62 • Treatment Emergent Adverse Events up to Day 360
1.6%
1/61 • Treatment Emergent Adverse Events up to Day 360

Additional Information

Global Health Science Center

The Medicine's Company

Phone: 1-888-997-6326

Results disclosure agreements

  • Principal investigator is a sponsor employee The only disclosure restriction on the PI is that Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of more than 60 days but less than/equal to 180 days from the time submitted to Sponsor for review, allowing Sponsor to file a patent application or take such other measures as Sponsor deems appropriate to establish and preserve its proprietary rights. Sponsor may remove confidential or proprietary information.
  • Publication restrictions are in place

Restriction type: OTHER