Trial Outcomes & Findings for Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol. (NCT NCT05888103)
NCT ID: NCT05888103
Last Updated: 2026-01-13
Results Overview
Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
207 participants
Primary outcome timeframe
Baseline, Day 150
Results posted on
2026-01-13
Participant Flow
Participant milestones
| Measure |
Inclisiran - Inclisiran
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
104
|
|
Overall Study
Completed extension part study
|
98
|
101
|
|
Overall Study
COMPLETED
|
100
|
101
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Inclisiran - Inclisiran
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Overall Study
Participant decision
|
3
|
3
|
Baseline Characteristics
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
Baseline characteristics by cohort
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 9.97 • n=9 Participants
|
47.7 years
STANDARD_DEVIATION 10.63 • n=6 Participants
|
47.9 years
STANDARD_DEVIATION 10.28 • n=9 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=9 Participants
|
63 Participants
n=6 Participants
|
121 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=9 Participants
|
41 Participants
n=6 Participants
|
86 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
103 Participants
n=9 Participants
|
104 Participants
n=6 Participants
|
207 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
-45.87 % change in LDL-C
Interval -49.33 to -42.42
|
1.62 % change in LDL-C
Interval -1.77 to 5.02
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Absolute Change in LDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
-69.05 mg/dL
Interval -73.95 to -64.15
|
0.68 mg/dL
Interval -4.13 to 5.49
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Inclisiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of protein convertase subtilisin/kexin type 9 (PCSK9) messenger RNA (mRNA) leading to the reduction of PCSK9 protein. The percentage change from baseline in PCSK9 at Day 150 was assessed.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part
|
-71.95 % change in PCSK9
Interval -77.68 to -66.22
|
5.88 % change in PCSK9
Interval 0.24 to 11.52
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Inclisiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of protein convertase subtilisin/kexin type 9 (PCSK9) messenger RNA (mRNA) leading to the reduction of PCSK9 protein.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Absolute Change in PCSK9 (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part
|
-217.14 ng/mL
Interval -230.15 to -204.13
|
9.47 ng/mL
Interval -3.24 to 22.17
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Total cholesterol is a measure of all the cholesterol in the blood. It includes low-density lipoprotein (LDL), high-density lipoprotein (HDL) and a portion of triglycerides.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Percentage Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
-29.88 % change in total cholesterol
Interval -32.32 to -27.43
|
1.61 % change in total cholesterol
Interval -0.78 to 4.01
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Total cholesterol is a measure of all the cholesterol in the blood. It includes low-density lipoprotein (LDL), high-density lipoprotein (HDL) and a portion of triglycerides.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Absolute Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
-68.82 mg/dL
Interval -74.37 to -63.28
|
2.64 mg/dL
Interval -2.8 to 8.09
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
HDL-C stands for high-density lipoprotein cholesterol, often referred to as the "good" cholesterol. This is because HDL cholesterol helps remove other forms of cholesterol from the bloodstream. It picks up excess cholesterol in the blood and carries it back to the liver, where it is broken down and flushed out of the body.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
12.24 % change in HDL-C
Interval 7.62 to 16.86
|
9.30 % change in HDL-C
Interval 4.74 to 13.86
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
HDL-C stands for high-density lipoprotein cholesterol, often referred to as the "good" cholesterol. This is because HDL cholesterol helps remove other forms of cholesterol from the bloodstream. It picks up excess cholesterol in the blood and carries it back to the liver, where it is broken down and flushed out of the body.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Absolute Change in HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
4.66 mg/dL
Interval 2.8 to 6.52
|
3.60 mg/dL
Interval 1.76 to 5.43
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Non-HDL cholesterol is a measure of all the "bad" types of cholesterol in the blood, excluding HDL cholesterol. It is calculated by subtracting HDL cholesterol from total cholesterol. Non-HDL cholesterol includes all the types of cholesterol other than HDL cholesterol, and higher levels of non-HDL cholesterol can increase the risk of cardiovascular disease.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Percentage Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
-40.71 % change in non-HDL-C
Interval -43.57 to -37.85
|
-0.14 % change in non-HDL-C
Interval -2.93 to 2.66
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Non-HDL cholesterol is a measure of all the "bad" types of cholesterol in the blood, excluding HDL cholesterol. It is calculated by subtracting HDL cholesterol from total cholesterol. Non-HDL cholesterol includes all the types of cholesterol other than HDL cholesterol, and higher levels of non-HDL cholesterol can increase the risk of cardiovascular disease.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Absolute Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
-73.48 mg/dL
Interval -78.63 to -68.33
|
-1.14 mg/dL
Interval -6.19 to 3.91
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Apolipoprotein B (ApoB) is a protein that helps carry fat and cholesterol through the body. It is encoded by the APOB gene. ApoB attaches to negative types of cholesterol that cause plaque buildup in blood vessels, which can lead to damage and heart disease.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Percentage Change in Apolipoprotein B (ApoB) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
-36.63 % change in apolipoprotein B
Interval -39.4 to -33.86
|
0.21 % change in apolipoprotein B
Interval -2.5 to 2.93
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Apolipoprotein B (ApoB) is a protein that helps carry fat and cholesterol through the body. It is encoded by the APOB gene. ApoB attaches to negative types of cholesterol that cause plaque buildup in blood vessels, which can lead to damage and heart disease.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Absolute Change in ApoB (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
-42.64 mg/dL
Interval -45.78 to -39.49
|
-0.76 mg/dL
Interval -3.85 to 2.32
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Apolipoprotein A1 (ApoA1) is the primary protein associated with high-density lipoprotein (HDL) particles, and plays a central role in reverse cholesterol transport. HDL cholesterol (HDL-C) and ApoA1 concentrations are inversely related to the risk for coronary artery disease (CAD).
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Percentage Change in Apolipoprotein A-1 (ApoA-1) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
5.11 % change in apolipoprotein A-1
Interval 2.34 to 7.88
|
3.06 % change in apolipoprotein A-1
Interval 0.33 to 5.79
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Apolipoprotein A1 (ApoA1) is the primary protein associated with high-density lipoprotein (HDL) particles, and plays a central role in reverse cholesterol transport. HDL cholesterol (HDL-C) and ApoA1 concentrations are inversely related to the risk for coronary artery disease (CAD).
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Absolute Change in ApoA-1 (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
6.44 mg/dL
Interval 2.72 to 10.16
|
3.31 mg/dL
Interval -0.35 to 6.98
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Often referred to as Lp(a), lipoprotein (a) is a type of lipoprotein that is genetically inherited and in high levels is a common independent risk factor for heart disease.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Percentage Change in Lipoprotein (a) (Lp(a)) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part
|
-23.84 % change in lipoprotein (a)
Interval -31.2 to -16.48
|
6.43 % change in lipoprotein (a)
Interval -0.77 to 13.62
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Often referred to as Lp(a), lipoprotein (a) is a type of lipoprotein that is genetically inherited and in high levels is a common independent risk factor for heart disease.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Absolute Change in Log-transformed Lp(a) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part
|
0.68 nmol/L
Interval 0.63 to 0.74
|
1.01 nmol/L
Interval 0.93 to 1.09
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Triglycerides are fats from the food we eat. Most of the fats we eat (like butter) are in triglyceride form. Extra calories, alcohol and sugar in the body turn into triglycerides. The body stores them in fat cells throughout the body.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Percentage Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
3.49 % change in Triglyceride
Interval -4.44 to 11.43
|
0.48 % change in Triglyceride
Interval -7.01 to 7.97
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full analysis set - all treated participants
Triglycerides are fats from the food we eat. Most of the fats we eat (like butter) are in triglyceride form. Extra calories, alcohol and sugar in the body turn into triglycerides. The body stores them in fat cells throughout the body.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Absolute Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part
|
-15.32 mg/dL
Interval -31.86 to 1.22
|
-7.36 mg/dL
Interval -23.67 to 8.94
|
SECONDARY outcome
Timeframe: Baseline, Day 330Population: Full analysis set - all treated participants in the Inclisiran - Inclisiran group
Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Percentage Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part
|
-45.45 % change in LDL-C
Interval -48.57 to -42.34
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 330Population: Full analysis set - all treated participants in the Inclisiran - Inclisiran group
Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body.
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Absolute Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part
|
-67.55 mg/dL
Interval -72.39 to -62.72
|
—
|
SECONDARY outcome
Timeframe: Core part, from treatment start (Day 1) to Day 150Population: Safety set - all treated participants in the core part
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) During Core Part
Adverse events (AEs)
|
73 Participants
|
70 Participants
|
|
Number of Participants With Adverse Events (AEs) During Core Part
-Adverse events Treatment-related
|
14 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs) During Core Part
Serious adverse events (SAEs)
|
5 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs) During Core Part
-SAEs Treatment-related
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) During Core Part
Fatal SAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) During Core Part
-Fatal SAEs Treatment-related
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) During Core Part
AEs leading to treatment discontinuation
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) During Core Part
-Treatment-related
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) During Core Part
AEs requiring additional therapy
|
52 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Extension part, from Day 181, up to Day 360Population: Final analysis - all treated participants in the extension part
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=100 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=101 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) During Extension Part
-Adverse events Treatment-related
|
9 Participants
|
15 Participants
|
|
Number of Participants With Adverse Events (AEs) During Extension Part
Serious adverse events (SAEs)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs) During Extension Part
-SAEs Treatment-related
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) During Extension Part
Fatal SAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) During Extension Part
-Fatal SAEs Treatment-related
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) During Extension Part
AEs leading to treatment discontinuation
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) During Extension Part
-Treatment-related
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) During Extension Part
AEs requiring additional therapy
|
36 Participants
|
28 Participants
|
|
Number of Participants With Adverse Events (AEs) During Extension Part
Adverse events (AEs)
|
52 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 daysPopulation: Final analysis - all treated participants (Core + Extension part)
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject
Outcome measures
| Measure |
Inclisiran - Inclisiran
n=103 Participants
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180
|
Placebo- Inclisiran
n=104 Participants
Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)
Adverse events
|
85 Participants
|
81 Participants
|
|
Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)
-Adverse events Treatment-related
|
18 Participants
|
18 Participants
|
|
Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)
SAEs
|
6 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)
-SAEs Treatment-related
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)
Fatal SAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)
-Fatal SAEs Treatment-related
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)
AEs leading to treatment discontinuation
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)
-Treatment-related
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part)
AEs requiring additional therapy
|
65 Participants
|
63 Participants
|
Adverse Events
Inclisiran - Inclisiran: Core Part
Serious events: 5 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo - Inclisiran: Core Part
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Inclisiran - Inclisiran: Extension Part
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo - Inclisiran: Extension Part
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inclisiran - Inclisiran: Core Part
n=103 participants at risk
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran): core part
|
Placebo - Inclisiran: Core Part
n=104 participants at risk
Placebo - inclisiran: core part
|
Inclisiran - Inclisiran: Extension Part
n=100 participants at risk
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran): extension part
|
Placebo - Inclisiran: Extension Part
n=101 participants at risk
Placebo - inclisiran: extension part
|
|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.97%
1/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.99%
1/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.97%
1/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.96%
1/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
1.0%
1/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Infections and infestations
Appendicitis
|
0.00%
0/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.99%
1/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.96%
1/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Infections and infestations
COVID-19
|
0.00%
0/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.96%
1/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.97%
1/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.97%
1/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.97%
1/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.97%
1/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Nervous system disorders
Cervical radiculopathy
|
0.97%
1/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
0.00%
0/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
Other adverse events
| Measure |
Inclisiran - Inclisiran: Core Part
n=103 participants at risk
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran): core part
|
Placebo - Inclisiran: Core Part
n=104 participants at risk
Placebo - inclisiran: core part
|
Inclisiran - Inclisiran: Extension Part
n=100 participants at risk
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran): extension part
|
Placebo - Inclisiran: Extension Part
n=101 participants at risk
Placebo - inclisiran: extension part
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
24.3%
25/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
16.3%
17/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
14.0%
14/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
8.9%
9/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Investigations
Alanine aminotransferase increased
|
5.8%
6/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
2.9%
3/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
5.0%
5/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
4.0%
4/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Investigations
Blood creatine phosphokinase increased
|
6.8%
7/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
5.8%
6/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
6.0%
6/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
6.9%
7/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
|
Investigations
Blood glucose increased
|
9.7%
10/103 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
6.7%
7/104 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
4.0%
4/100 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
3.0%
3/101 • AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER