Trial Outcomes & Findings for Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody (NCT NCT02189837)
NCT ID: NCT02189837
Last Updated: 2018-10-03
Results Overview
The fractional catabolic rate (the percentage of apolipoprotein B-100 in LDL which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation, and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
89 participants
Primary outcome timeframe
Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.
Results posted on
2018-10-03
Participant Flow
This study was conducted at 2 centers in Australia. The first participant was enrolled on 08 July 2014, and the last participant enrolled on 15 December 2014.
Participants who met eligibility criteria underwent an initial 4 week run-in period of dietary stabilization before randomization. Randomization was stratified based on screening low-density lipoprotein (LDL-C) concentration (\< 130 mg/dL vs ≥ 130 mg/dL)
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Atorvastatin
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
Evolocumab
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Evolocumab and Atorvastatin
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
23
|
21
|
|
Overall Study
Received Treatment
|
21
|
22
|
22
|
20
|
|
Overall Study
COMPLETED
|
20
|
22
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Atorvastatin
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
Evolocumab
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Evolocumab and Atorvastatin
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
3
|
1
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
Baseline characteristics by cohort
| Measure |
Placebo
n=21 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Atorvastatin
n=22 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
Evolocumab
n=22 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Evolocumab and Atorvastatin
n=20 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
31.0 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
32.2 years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
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
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
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
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race/Ethnicity, Customized
White
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
14 participants
n=4 Participants
|
73 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Mixed 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
|
|
Screening LDL-C Level
< 130 mg/dL
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
35 participants
n=21 Participants
|
|
Screening LDL-C Level
≥ 130 mg/dL
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
12 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
LDL-C Concentration
|
118.1 mg/dL
STANDARD_DEVIATION 18.1 • n=5 Participants
|
123.2 mg/dL
STANDARD_DEVIATION 21.3 • n=7 Participants
|
118.2 mg/dL
STANDARD_DEVIATION 18.4 • n=5 Participants
|
116.5 mg/dL
STANDARD_DEVIATION 23.7 • n=4 Participants
|
119.1 mg/dL
STANDARD_DEVIATION 20.2 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.Population: Efficacy Analysis Set including all randomized and dosed participants who completed baseline and Day 50 measurements.
The fractional catabolic rate (the percentage of apolipoprotein B-100 in LDL which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation, and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Atorvastatin
n=22 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
Evolocumab
n=20 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Evolocumab and Atorvastatin
n=19 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Low-density Lipoprotein (LDL) Apolipoprotein B-100 Fractional Catabolic Rate (FCR)
|
-5.07 percent change
Standard Error 26.06
|
74.13 percent change
Standard Error 24.84
|
83.70 percent change
Standard Error 26.06
|
310.48 percent change
Standard Error 26.68
|
SECONDARY outcome
Timeframe: Baseline and Day 50Population: Efficacy Analysis Set with available data at both time points
LDL-C was measured using ultrcentrifugation.
Outcome measures
| Measure |
Placebo
n=19 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Atorvastatin
n=22 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
Evolocumab
n=18 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Evolocumab and Atorvastatin
n=17 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in LDL-C at Day 50
|
-0.65 percent change
Standard Error 3.09
|
-45.25 percent change
Standard Error 2.86
|
-57.79 percent change
Standard Error 3.15
|
-83.19 percent change
Standard Error 3.24
|
SECONDARY outcome
Timeframe: Baseline and Day 50Population: Efficacy Analysis Set
The production rate of apolipoprotein B-100 in LDL was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate the production rate.
Outcome measures
| Measure |
Placebo
n=20 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Atorvastatin
n=22 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
Evolocumab
n=20 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Evolocumab and Atorvastatin
n=19 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in LDL Apolipoprotein B-100 Production Rate (PR)
|
-3.80 percent change
Standard Error 7.40
|
-3.27 percent change
Standard Error 7.05
|
-20.45 percent change
Standard Error 7.40
|
-35.93 percent change
Standard Error 7.57
|
SECONDARY outcome
Timeframe: Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.Population: Efficacy Analysis Set with available data
The fractional catabolic rate (the percentage of lipoprotein(a) (Lp\[a\]) which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. Lp(a) was isolated from plasma using an immunoprecipitation method employing immunomagnetic beads and polyacrylamide gel electrophoresis. Isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Atorvastatin
n=17 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
Evolocumab
n=14 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Evolocumab and Atorvastatin
n=16 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein (a) Fractional Catabolic Rate (FCR)
|
7.49 percent change
Standard Error 9.17
|
25.52 percent change
Standard Error 8.92
|
5.37 percent change
Standard Error 9.81
|
64.57 percent change
Standard Error 9.23
|
SECONDARY outcome
Timeframe: Baseline and Day 50Population: Efficacy Analysis Set with available data
The production rate of lipoprotein(a) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. Lp(a) was isolated from plasma using an immunoprecipitation method employing immunomagnetic beads and polyacrylamide gel electrophoresis. Isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Atorvastatin
n=17 Participants
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
Evolocumab
n=14 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Evolocumab and Atorvastatin
n=16 Participants
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) Production Rate (PR)
|
3.52 percent change
Standard Error 7.94
|
-6.88 percent change
Standard Error 7.72
|
-35.91 percent change
Standard Error 8.49
|
16.40 percent change
Standard Error 7.99
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Atorvastatin
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Evolocumab
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Evolocumab and Atorvastatin
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=21 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Atorvastatin
n=22 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
Evolocumab
n=22 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Evolocumab and Atorvastatin
n=20 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/21 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Placebo
n=21 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Atorvastatin
n=22 participants at risk
Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
Evolocumab
n=22 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
|
Evolocumab and Atorvastatin
n=20 participants at risk
Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.1%
2/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.6%
3/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.1%
2/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
2/20 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Influenza like illness
|
0.00%
0/21 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.1%
2/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
1/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.1%
2/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/21 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.1%
2/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
1/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/21 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.1%
2/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/21 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.1%
2/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
1/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
2/20 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.1%
2/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
1/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
22.7%
5/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
36.4%
8/22 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
35.0%
7/20 • From first dose of study drug until day 73
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER