Trial Outcomes & Findings for A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance (NCT NCT01751984)
NCT ID: NCT01751984
Last Updated: 2022-04-04
Results Overview
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. Least square (LS) mean percent change from Baseline to Week 8 was based on an analysis of covariance (ANCOVA) model with effects of treatment and Baseline value as a covariate. Missing LDL-C values at Week 8 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Baseline; 8 weeks
Results posted on
2022-04-04
Participant Flow
Participant milestones
| Measure |
ETC-1002
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
19
|
|
Overall Study
COMPLETED
|
31
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
ETC-1002
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Per Investigator/Sponsor/Regulatory Body
|
1
|
0
|
Baseline Characteristics
Only participants with available data were analyzed.
Baseline characteristics by cohort
| Measure |
ETC-1002
n=37 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=19 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 5.42 • n=37 Participants
|
60.4 years
STANDARD_DEVIATION 7.88 • n=19 Participants
|
62.8 years
STANDARD_DEVIATION 6.51 • n=56 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=37 Participants
|
11 Participants
n=19 Participants
|
28 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=37 Participants
|
8 Participants
n=19 Participants
|
28 Participants
n=56 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=37 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=56 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=37 Participants
|
19 Participants
n=19 Participants
|
54 Participants
n=56 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=56 Participants
|
|
Calculated Low-density Lipoprotein Cholesterol (LDL-C)
|
175.7 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 36.52 • n=36 Participants • Only participants with available data were analyzed.
|
184.8 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 32.53 • n=19 Participants • Only participants with available data were analyzed.
|
178.9 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 35.16 • n=55 Participants • Only participants with available data were analyzed.
|
PRIMARY outcome
Timeframe: Baseline; 8 weeksPopulation: Modified Intent-to-Treat (mITT) Population: All randomized participants who received at least 1 dose of study medication and had a Baseline assessment and at least 1 post-Baseline assessment, excluding any assessments taken more than 2 days after a dose of study medication. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. Least square (LS) mean percent change from Baseline to Week 8 was based on an analysis of covariance (ANCOVA) model with effects of treatment and Baseline value as a covariate. Missing LDL-C values at Week 8 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Outcome measures
| Measure |
ETC-1002
n=35 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=18 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)
|
-32.0 Percent Change
Standard Error 1.93
|
-3.3 Percent Change
Standard Error 2.69
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 6, and 8Population: Completers Population: All randomized participants who received at least 1 dose of study medication and had a Baseline assessment and an assessment at the specified time point, excluding any assessments taken more than 2 days after a dose of study medication. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. A negative percent change from Baseline reflects clinical improvement.
Outcome measures
| Measure |
ETC-1002
n=36 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=18 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C
Week 2
|
-19.5 Percent Change
Standard Error 1.83
|
-1.4 Percent Change
Standard Error 2.52
|
|
Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C
Week 4
|
-31.0 Percent Change
Standard Error 1.50
|
-1.0 Percent Change
Standard Error 2.12
|
|
Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C
Week 6
|
-32.6 Percent Change
Standard Error 2.28
|
-3.8 Percent Change
Standard Error 3.28
|
|
Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C
Week 8
|
-32.6 Percent Change
Standard Error 2.48
|
-4.0 Percent Change
Standard Error 3.51
|
SECONDARY outcome
Timeframe: Baseline; 8 weeksPopulation: mITT Population. The participant composition of this population could change depending on the parameter being analyzed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Outcome measures
| Measure |
ETC-1002
n=36 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=18 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 8 in High-Density Lipoprotein-Cholesterol (HDL-C)
|
-8.2 Percent Change
Standard Deviation 2.46
|
-2.4 Percent Change
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: Baseline; 8 weeksPopulation: mITT Population. The participant composition of this population could change depending on the parameter being analyzed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Outcome measures
| Measure |
ETC-1002
n=36 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=18 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 8 in Non-HDL-C
|
-25.4 Percent Change
Standard Error 2.04
|
-4.4 Percent Change
Standard Error 2.88
|
SECONDARY outcome
Timeframe: Baseline; 8 weeksPopulation: mITT Population. The participant composition of this population could change depending on the parameter being analyzed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Outcome measures
| Measure |
ETC-1002
n=36 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=18 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 8 in Total Cholesterol
|
-22.2 Percent Change
Standard Error 1.64
|
-3.7 Percent Change
Standard Error 2.32
|
SECONDARY outcome
Timeframe: Baseline; 8 weeksPopulation: mITT Population. The participant composition of this population could change depending on the parameter being analyzed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Outcome measures
| Measure |
ETC-1002
n=36 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=18 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 8 in Triglycerides
|
11.2 Percent Change
Standard Error 6.34
|
-7.4 Percent Change
Standard Error 8.98
|
SECONDARY outcome
Timeframe: Baseline; 8 weeksPopulation: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Outcome measures
| Measure |
ETC-1002
n=29 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=14 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 8 in Apolipoprotein B
|
-19.7 Percent Change
Standard Error 2.61
|
-4.4 Percent Change
Standard Error 3.77
|
SECONDARY outcome
Timeframe: Baseline; 8 weeksPopulation: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.
Outcome measures
| Measure |
ETC-1002
n=29 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=14 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 8 in Apolipoprotein AI
|
-4.2 Percent Change
Standard Error 2.04
|
0.1 Percent Change
Standard Error 2.98
|
SECONDARY outcome
Timeframe: Baseline; 8 weeksPopulation: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data are based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. Lipoprotein (a) results indicated as \<3 in the laboratory data were set to 3 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement.
Outcome measures
| Measure |
ETC-1002
n=29 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=14 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 8 in Lipoprotein (a)
|
10.4 Percent Change
Standard Error 5.78
|
-1.2 Percent Change
Standard Error 8.32
|
SECONDARY outcome
Timeframe: Baseline; 8 weeksPopulation: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. hsCRP results indicated as \<0.2 in the laboratory data were set to 0.2 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement.
Outcome measures
| Measure |
ETC-1002
n=28 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=14 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 8 in High-Sensitivity C-Reactive Protein (hsCRP)
|
-22.6 Percent Change
Standard Error 11.77
|
1.1 Percent Change
Standard Error 16.74
|
SECONDARY outcome
Timeframe: Baseline; 8 weeksPopulation: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value.
Outcome measures
| Measure |
ETC-1002
n=28 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=14 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Percent Change From Baseline to Week 8 in Free Fatty Acids (FFA)
|
14.3 Percent Change
Standard Error 7.99
|
10.4 Percent Change
Standard Error 11.31
|
SECONDARY outcome
Timeframe: Baseline; up to 8 weeksPopulation: mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed.
Participants were analyzed to evaluate the LDL-C target of \<100 mg/dL for high risk participants with cardiovascular diseases. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward).
Outcome measures
| Measure |
ETC-1002
n=34 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=17 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment
Week 8: Achieved LDL-C Goal
|
21 Participants
|
0 Participants
|
|
Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment
Week 8: Did Not Achieve LDL-C Goal
|
13 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: Safety Population: all randomized participants who received at least 1 dose of study medication
TEAEs were defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication.
Outcome measures
| Measure |
ETC-1002
n=37 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=19 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Number or Participants With Treatment-emergent Adverse Events (TEAEs)
|
26 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: Safety Population
TEAEs were defined as AEs that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication.
Outcome measures
| Measure |
ETC-1002
n=37 Participants
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=19 Participants
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Number of Participants With Muscle-Related TEAEs
|
12 Participants
|
7 Participants
|
Adverse Events
ETC-1002
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ETC-1002
n=37 participants at risk
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=19 participants at risk
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
2.7%
1/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
ETC-1002
n=37 participants at risk
Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks.
|
Placebo
n=19 participants at risk
Participants received placebo QD on Day 1 for 8 weeks.
|
|---|---|---|
|
Eye disorders
Eye Swelling
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Change Of Bowel Habit
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
8.1%
3/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
2.7%
1/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
5.4%
2/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Oedema
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
2/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Rhinovirus Infection
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.7%
1/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
21.1%
4/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary Tract Infection
|
8.1%
3/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Investigations
White Blood Cells Urine Positive
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
1/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
10.5%
2/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle Fatigue
|
2.7%
1/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
13.5%
5/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
2.7%
1/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
2.7%
1/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
10.5%
2/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
10.5%
2/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
1/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.4%
2/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
5.4%
2/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
2.7%
1/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/37 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
5.3%
1/19 • up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place