Trial Outcomes & Findings for MK-0524B Lipid Study (MK-0524B-063) (NCT NCT00479882)
NCT ID: NCT00479882
Last Updated: 2019-02-06
Results Overview
Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2414 participants
Primary outcome timeframe
Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)
Results posted on
2019-02-06
Participant Flow
Participants completed a 6-8 week washout then completed a 2-week placebo run-in prior to the start of active treatment. Includes 6 participants who had an adverse event that began during the placebo run-in but did not lead to discontinuation until after randomization in Period I or II.
Participant milestones
| Measure |
Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg
After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
|
Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
|
Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg
After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
|
|---|---|---|---|---|
|
Precrossover: Periods I/II (Weeks 1-12)
STARTED
|
610
|
602
|
597
|
605
|
|
Precrossover: Periods I/II (Weeks 1-12)
COMPLETED
|
472
|
440
|
440
|
465
|
|
Precrossover: Periods I/II (Weeks 1-12)
NOT COMPLETED
|
138
|
162
|
157
|
140
|
|
Crossover: Period III (Weeks 13-20)
STARTED
|
472
|
440
|
440
|
465
|
|
Crossover: Period III (Weeks 13-20)
COMPLETED
|
447
|
419
|
420
|
447
|
|
Crossover: Period III (Weeks 13-20)
NOT COMPLETED
|
25
|
21
|
20
|
18
|
Reasons for withdrawal
| Measure |
Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg
After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
|
Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
|
Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg
After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
|
|---|---|---|---|---|
|
Precrossover: Periods I/II (Weeks 1-12)
Clinical Adverse Event
|
96
|
99
|
98
|
87
|
|
Precrossover: Periods I/II (Weeks 1-12)
Laboratory Adverse Event
|
0
|
4
|
4
|
4
|
|
Precrossover: Periods I/II (Weeks 1-12)
Lost to Follow-up
|
12
|
9
|
9
|
11
|
|
Precrossover: Periods I/II (Weeks 1-12)
Other
|
4
|
6
|
9
|
5
|
|
Precrossover: Periods I/II (Weeks 1-12)
Participant moved
|
0
|
4
|
2
|
1
|
|
Precrossover: Periods I/II (Weeks 1-12)
Withdrawal by Subject
|
24
|
33
|
30
|
25
|
|
Precrossover: Periods I/II (Weeks 1-12)
Protocol Violation
|
2
|
7
|
5
|
7
|
|
Crossover: Period III (Weeks 13-20)
Clinical Adverse Event
|
12
|
13
|
12
|
10
|
|
Crossover: Period III (Weeks 13-20)
Laboratory Adverse Event
|
3
|
1
|
2
|
2
|
|
Crossover: Period III (Weeks 13-20)
Lost to Follow-up
|
1
|
2
|
1
|
1
|
|
Crossover: Period III (Weeks 13-20)
Other
|
5
|
0
|
2
|
2
|
|
Crossover: Period III (Weeks 13-20)
Participant moved
|
1
|
2
|
1
|
0
|
|
Crossover: Period III (Weeks 13-20)
Withdrawal by Subject
|
3
|
3
|
1
|
3
|
|
Crossover: Period III (Weeks 13-20)
Protocol Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
MK-0524B Lipid Study (MK-0524B-063)
Baseline characteristics by cohort
| Measure |
Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg
n=610 Participants
After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
|
Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg
n=602 Participants
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
|
Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg
n=597 Participants
After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg
n=605 Participants
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
|
Total
n=2414 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
491 Participants
n=5 Participants
|
470 Participants
n=7 Participants
|
468 Participants
n=5 Participants
|
477 Participants
n=4 Participants
|
1906 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
119 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
508 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
325 Participants
n=5 Participants
|
334 Participants
n=7 Participants
|
313 Participants
n=5 Participants
|
316 Participants
n=4 Participants
|
1288 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
285 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
289 Participants
n=4 Participants
|
1126 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)Population: Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.
Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=844 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=844 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=843 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=843 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
|
-44.6 Percentage Change
Interval -45.3 to -43.8
|
-46.9 Percentage Change
Interval -47.7 to -46.2
|
-48.9 Percentage Change
Interval -49.7 to -48.2
|
-50.4 Percentage Change
Interval -51.1 to -49.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)Population: Participants who completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.
Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=845 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=845 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=845 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=845 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
|
27.4 Percentage Change
Interval 26.5 to 28.2
|
27.6 Percentage Change
Interval 26.7 to 28.4
|
27.7 Percentage Change
Interval 26.9 to 28.4
|
28.5 Percentage Change
Interval 27.8 to 29.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST ULNs for males and females were 43 U/L and 36 U/L, respectively. The ALT ULNs for males and females were 40 U/L and 33 U/L, respectively.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=588 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=580 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=469 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=437 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=568 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=592 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=438 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=464 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)
|
0.3 Percentage of Participants
|
0.5 Percentage of Participants
|
0.6 Percentage of Participants
|
0.9 Percentage of Participants
|
0.7 Percentage of Participants
|
1.0 Percentage of Participants
|
0.5 Percentage of Participants
|
0.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=588 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=580 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=469 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=437 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=568 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=592 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=438 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=464 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Creatine Kinase (CK) >=10 x ULN
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.4 Percentage of Participants
|
0.0 Percentage of Participants
|
0.4 Percentage of Participants
|
0.2 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=588 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=580 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=469 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=437 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=568 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=592 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=438 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=464 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With CK >=10 x ULN With Muscle Symptoms
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=588 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=580 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=469 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=437 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=568 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=592 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=438 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=464 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants who had normal fasting blood glucose levels at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
Participants had fasting glucose levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became 'impaired' during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=484 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=473 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=468 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=483 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=365 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=343 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=345 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=372 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose
|
0.0 Percentage of Participants
|
0.2 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities \[MedDRA\] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=554 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=551 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=427 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=404 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=545 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=545 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=404 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=422 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With New Diagnosis of Diabetes
|
0.4 Percentage of Participants
|
0.7 Percentage of Participants
|
0.5 Percentage of Participants
|
0.7 Percentage of Participants
|
0.6 Percentage of Participants
|
0.4 Percentage of Participants
|
0.7 Percentage of Participants
|
0.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants with diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
Participants with diabetes at baseline and who experienced a worsening of the diabetes identified through adverse event reports using a pre-defined set of terms and/or increasing dose/adding a new anti-diabetic medication.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=56 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=51 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=45 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=36 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=52 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=60 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=36 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=43 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline
|
1.8 Percentage of Participants
|
15.7 Percentage of Participants
|
4.4 Percentage of Participants
|
8.3 Percentage of Participants
|
3.8 Percentage of Participants
|
8.3 Percentage of Participants
|
8.3 Percentage of Participants
|
11.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee as cardiovascular events were recorded
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=610 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=602 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=472 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=597 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=605 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=465 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.2 Percentage of Participants
|
0.0 Percentage of Participants
|
0.2 Percentage of Participants
|
0.0 Percentage of Participants
|
0.2 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=610 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=602 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=472 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=597 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=605 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=465 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)
|
67.5 Percentage of Participants
|
68.9 Percentage of Participants
|
35.6 Percentage of Participants
|
37.5 Percentage of Participants
|
67.5 Percentage of Participants
|
67.4 Percentage of Participants
|
32.3 Percentage of Participants
|
35.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=610 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=602 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=472 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=597 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=605 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=465 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least 1 Laboratory AE
|
3.9 Percentage of Participants
|
4.2 Percentage of Participants
|
5.9 Percentage of Participants
|
3.6 Percentage of Participants
|
6.2 Percentage of Participants
|
4.6 Percentage of Participants
|
5.9 Percentage of Participants
|
3.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined, where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover). Excludes 6 participants who had an AE that began during the placebo run-in.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=610 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=602 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=472 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=597 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=605 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=465 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE
|
15.9 Percentage of Participants
|
15.9 Percentage of Participants
|
1.9 Percentage of Participants
|
2.7 Percentage of Participants
|
16.4 Percentage of Participants
|
14.4 Percentage of Participants
|
2.5 Percentage of Participants
|
1.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=610 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=602 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=472 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=597 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=605 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=465 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE
|
0.0 Percentage of Participants
|
0.7 Percentage of Participants
|
0.6 Percentage of Participants
|
0.2 Percentage of Participants
|
0.7 Percentage of Participants
|
0.8 Percentage of Participants
|
0.5 Percentage of Participants
|
0.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)Population: All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Non-serious Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=610 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=602 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=472 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
n=597 Participants
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=605 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=440 Participants
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=465 Participants
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least 1 Hepatitis-related Non-serious Clinical AE
|
0.2 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.2 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Day1 of Period I) and Week 4Population: Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.
Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the LDL-C levels. The change from baseline after 4 weeks of treatment was recorded.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=582 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=574 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=556 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=581 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in LDL-C at Week 4
|
-34.8 Percentage Change
Interval -36.6 to -33.0
|
-35.8 Percentage Change
Interval -37.6 to -34.0
|
-42.2 Percentage Change
Interval -44.3 to -40.0
|
-45.8 Percentage Change
Interval -48.0 to -43.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day1 of Period I) and Week 4Population: Participants that completed the study and had respective endpoint data available at baseline and end of each treatment period. End of period value was defined as measurements collected on the same date as the corresponding end of period visit date. Results were reported by dose of study drug taken and not by randomly assigned sequence.
Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the HDL-C levels. The change from baseline after 4 weeks of treatment was recorded.
Outcome measures
| Measure |
MK-0524B 1.8g/20mg
n=582 Participants
Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 20mg
n=575 Participants
Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
MK-0524B 1.8g/40mg
n=555 Participants
Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
|
MK-0524A 2g+Simvastatin 40mg
n=583 Participants
Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
|
Sequence 3: MK-0524B 1.8g/40mg
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in HDL-C at Week 4
|
18.3 Percentage Change
Interval 16.6 to 19.9
|
18.7 Percentage Change
Interval 17.0 to 20.3
|
19.8 Percentage Change
Interval 17.9 to 21.6
|
19.6 Percentage Change
Interval 17.8 to 21.4
|
—
|
—
|
—
|
—
|
Adverse Events
Sequence 1: MK-0524B 1.8g/20mg
Serious events: 3 serious events
Other events: 225 other events
Deaths: 0 deaths
Sequence 2: MK-0524A 2g+Simvastatin 20mg
Serious events: 6 serious events
Other events: 227 other events
Deaths: 0 deaths
Sequence 1: MK-0524A 2g+Simvastatin 20mg
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Sequence 2: MK-0524B 1.8g/20mg
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Sequence 3: MK-0524B 1.8g/40mg
Serious events: 12 serious events
Other events: 222 other events
Deaths: 0 deaths
Sequence 4: MK-0524A 2g+Simvastatin 40mg
Serious events: 9 serious events
Other events: 237 other events
Deaths: 0 deaths
Sequence 3: MK-0524A 2g+Simvastatin 40mg
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Sequence 4: MK-0524B 1.8g/40mg
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sequence 1: MK-0524B 1.8g/20mg
n=610 participants at risk
Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
|
Sequence 2: MK-0524A 2g+Simvastatin 20mg
n=602 participants at risk
Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Periods I/II
|
Sequence 1: MK-0524A 2g+Simvastatin 20mg
n=472 participants at risk
Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Period III
|
Sequence 2: MK-0524B 1.8g/20mg
n=440 participants at risk
Participants who received MK-0524B 1.8g/20mg during Periods III
|
Sequence 3: MK-0524B 1.8g/40mg
n=597 participants at risk
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=605 participants at risk
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=440 participants at risk
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=465 participants at risk
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.22%
1/465 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.21%
1/472 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.22%
1/465 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.23%
1/440 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
General disorders
Chest pain
|
0.16%
1/610 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/602 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.16%
1/610 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.21%
1/472 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/602 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Infections and infestations
Cystitis
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Infections and infestations
Viral infection
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/602 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Injury, poisoning and procedural complications
Device migration
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/602 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.23%
1/440 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.45%
2/440 • Number of events 2 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.21%
1/472 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.23%
1/440 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal neoplasm benign
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/602 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.16%
1/610 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.22%
1/465 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.21%
1/472 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.23%
1/440 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/602 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/597 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/610 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.17%
1/605 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Vascular disorders
Hypotension
|
0.16%
1/610 • Number of events 1 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/602 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/472 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/597 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/605 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/440 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
0.00%
0/465 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
Other adverse events
| Measure |
Sequence 1: MK-0524B 1.8g/20mg
n=610 participants at risk
Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
|
Sequence 2: MK-0524A 2g+Simvastatin 20mg
n=602 participants at risk
Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Periods I/II
|
Sequence 1: MK-0524A 2g+Simvastatin 20mg
n=472 participants at risk
Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Period III
|
Sequence 2: MK-0524B 1.8g/20mg
n=440 participants at risk
Participants who received MK-0524B 1.8g/20mg during Periods III
|
Sequence 3: MK-0524B 1.8g/40mg
n=597 participants at risk
Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
|
Sequence 4: MK-0524A 2g+Simvastatin 40mg
n=605 participants at risk
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
|
Sequence 3: MK-0524A 2g+Simvastatin 40mg
n=440 participants at risk
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
|
Sequence 4: MK-0524B 1.8g/40mg
n=465 participants at risk
Participants who received MK-0524B 1.8g/40mg during Periods III
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
28/610 • Number of events 32 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
5.5%
33/602 • Number of events 41 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
2.1%
10/472 • Number of events 10 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
3.4%
15/440 • Number of events 17 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
4.5%
27/597 • Number of events 29 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
6.1%
37/605 • Number of events 39 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
1.8%
8/440 • Number of events 8 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
2.8%
13/465 • Number of events 15 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Nervous system disorders
Headache
|
3.0%
18/610 • Number of events 19 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
5.3%
32/602 • Number of events 35 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
1.1%
5/472 • Number of events 6 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
2.0%
9/440 • Number of events 10 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
4.0%
24/597 • Number of events 25 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
4.6%
28/605 • Number of events 31 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
1.4%
6/440 • Number of events 8 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
1.7%
8/465 • Number of events 9 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.0%
67/610 • Number of events 79 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
12.0%
72/602 • Number of events 84 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
1.9%
9/472 • Number of events 11 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
3.4%
15/440 • Number of events 17 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
8.4%
50/597 • Number of events 54 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
12.4%
75/605 • Number of events 93 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
1.1%
5/440 • Number of events 5 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
1.5%
7/465 • Number of events 7 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
|
Vascular disorders
Flushing
|
25.4%
155/610 • Number of events 189 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
21.9%
132/602 • Number of events 166 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
4.9%
23/472 • Number of events 34 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
3.4%
15/440 • Number of events 20 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
27.1%
162/597 • Number of events 189 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
25.0%
151/605 • Number of events 179 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
3.2%
14/440 • Number of events 15 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
4.1%
19/465 • Number of events 23 • up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER