Trial Outcomes & Findings for A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001) (NCT NCT00960934)
NCT ID: NCT00960934
Last Updated: 2015-02-18
Results Overview
Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\^2).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
383 participants
Primary outcome timeframe
Baseline (BL) and Month 6
Results posted on
2015-02-18
Participant Flow
383 participants were randomized on study and 380 participants were treated on study.
Participant milestones
| Measure |
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
64
|
64
|
64
|
64
|
|
Overall Study
Number Treated
|
64
|
62
|
64
|
64
|
63
|
63
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
64
|
63
|
64
|
64
|
64
|
64
|
Reasons for withdrawal
| Measure |
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
3
|
2
|
4
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
2
|
1
|
5
|
4
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
1
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
3
|
4
|
0
|
3
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
4
|
5
|
5
|
7
|
|
Overall Study
Study Terminated by Sponsor
|
50
|
46
|
52
|
50
|
49
|
49
|
Baseline Characteristics
A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)
Baseline characteristics by cohort
| Measure |
MK-5442 2.5 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=63 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
Total
n=383 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
67.4 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
66.5 years
STANDARD_DEVIATION 5.4 • n=21 Participants
|
67.6 years
STANDARD_DEVIATION 6.7 • n=10 Participants
|
67.2 years
STANDARD_DEVIATION 6.2 • n=115 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
383 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline (BL) and Month 6Population: Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\^2).
Outcome measures
| Measure |
MK-5442 2.5 mg
n=58 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=54 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=55 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)
|
0.74 percent change
Interval -0.21 to 1.68
|
1.50 percent change
Interval 0.53 to 2.48
|
0.92 percent change
Interval -0.02 to 1.87
|
1.69 percent change
Interval 0.73 to 2.64
|
1.13 percent change
Interval 0.18 to 2.08
|
0.57 percent change
Interval -0.4 to 1.55
|
PRIMARY outcome
Timeframe: Baseline through Month 6Population: All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.
Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (\>2.5 mmol/L). Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.
Outcome measures
| Measure |
MK-5442 2.5 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=62 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=63 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=63 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change
|
7.8 Percentage of participants
|
32.3 Percentage of participants
|
32.8 Percentage of participants
|
56.3 Percentage of participants
|
73.0 Percentage of participants
|
3.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline through Month 6Population: All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.
Albumin-Corrected Calcium = (\[4 - plasma albumin in g/dL\] × 0.8 + serum calcium). ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.
Outcome measures
| Measure |
MK-5442 2.5 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=62 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=63 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=63 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change
|
0.0 Percentage of participants
|
9.7 Percentage of participants
Interval 2.96 to 5.35
|
18.8 Percentage of participants
Interval 2.75 to 5.09
|
37.5 Percentage of participants
Interval 4.28 to 6.69
|
49.2 Percentage of participants
Interval 5.1 to 7.5
|
1.6 Percentage of participants
Interval -1.04 to 1.22
|
PRIMARY outcome
Timeframe: Baseline through Month 6Population: All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.
Evidence of kidney stone(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.
Outcome measures
| Measure |
MK-5442 2.5 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=62 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=63 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=63 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Kidney Stones
|
1.6 Percentage of participants
|
1.6 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline through Month 6Population: All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.
Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.
Outcome measures
| Measure |
MK-5442 2.5 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=62 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=64 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=63 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=63 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Bone Neoplasms
|
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: Baseline and Month 6Population: Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
DXA was used to assess and measure aBMD of the total hip. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\^2).
Outcome measures
| Measure |
MK-5442 2.5 mg
n=58 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=54 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=55 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD
|
-0.20 percent change
Interval -0.95 to 0.55
|
-0.32 percent change
Interval -1.1 to 0.46
|
0.32 percent change
Interval -0.43 to 1.07
|
0.07 percent change
Interval -0.69 to 0.82
|
0.33 percent change
Interval -0.43 to 1.08
|
0.08 percent change
Interval -0.69 to 0.86
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
DXA was used to assess and measure aBMD of the femoral neck. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\^2).
Outcome measures
| Measure |
MK-5442 2.5 mg
n=58 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=54 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=55 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD
|
1.23 percent change
Interval 0.21 to 2.25
|
-0.52 percent change
Interval -1.58 to 0.54
|
0.12 percent change
Interval -0.89 to 1.14
|
-0.20 percent change
Interval -1.23 to 0.83
|
0.54 percent change
Interval -0.48 to 1.56
|
-0.04 percent change
Interval -1.09 to 1.01
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
DXA was used to assess and measure aBMD of the trochanter. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\^2).
Outcome measures
| Measure |
MK-5442 2.5 mg
n=58 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=54 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=55 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=56 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD
|
0.41 percent change
Interval -0.78 to 1.6
|
0.95 percent change
Interval -0.29 to 2.19
|
0.54 percent change
Interval -0.65 to 1.74
|
0.49 percent change
Interval -0.72 to 1.7
|
1.10 percent change
Interval -0.11 to 2.3
|
0.49 percent change
Interval -0.74 to 1.73
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
DXA was used to assess and measure aBMD of the total body. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\^2).
Outcome measures
| Measure |
MK-5442 2.5 mg
n=51 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=51 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=54 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=50 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=53 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD
|
0.43 percent change
Interval -0.11 to 0.97
|
0.28 percent change
Interval -0.28 to 0.84
|
0.80 percent change
Interval 0.27 to 1.33
|
0.21 percent change
Interval -0.35 to 0.76
|
0.09 percent change
Interval -0.44 to 0.63
|
0.27 percent change
Interval -0.29 to 0.82
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
DXA was used to assess and measure aBMD of the distal 1/3 forearm. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm\^2).
Outcome measures
| Measure |
MK-5442 2.5 mg
n=51 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=51 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=55 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=49 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=53 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD
|
-0.47 percent change
Interval -1.42 to 0.48
|
-0.32 percent change
Interval -1.3 to 0.65
|
0.44 percent change
Interval -0.47 to 1.36
|
-0.49 percent change
Interval -1.46 to 0.48
|
-0.56 percent change
Interval -1.5 to 0.37
|
-0.21 percent change
Interval -1.18 to 0.76
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
Quantitative computed tomography (QCT) technology was used to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).
Outcome measures
| Measure |
MK-5442 2.5 mg
n=42 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=43 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=46 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=39 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=41 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=50 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip
|
-0.41 percent change
Interval -1.44 to 0.62
|
-0.34 percent change
Interval -1.43 to 0.75
|
-0.89 percent change
Interval -1.9 to 0.13
|
-0.88 percent change
Interval -1.97 to 0.22
|
-0.80 percent change
Interval -1.87 to 0.26
|
-0.37 percent change
Interval -1.37 to 0.63
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
Quantitative computed tomography (QCT) technology was used at baseline and periodically through out the study to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).
Outcome measures
| Measure |
MK-5442 2.5 mg
n=43 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=43 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=44 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=39 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=40 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=50 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine
|
1.94 percent change
Interval 0.13 to 3.75
|
0.94 percent change
Interval -0.97 to 2.85
|
1.83 percent change
Interval 0.02 to 3.64
|
3.35 percent change
Interval 1.43 to 5.27
|
1.06 percent change
Interval -0.83 to 2.96
|
1.43 percent change
Interval -0.33 to 3.19
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.
The ratio of u-NTx to Cr is a biomarker for bone resorption. It is measured in the serum in units of nanomoles (nm) of bone collagen equivalents (BCE)/millimoles of creatinine (Cr).
Outcome measures
| Measure |
MK-5442 2.5 mg
n=50 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=51 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=53 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=51 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=53 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)
|
-12.18 percent change
Interval -21.23 to -2.1
|
-9.46 percent change
Interval -18.87 to 1.03
|
-20.73 percent change
Interval -28.79 to -11.76
|
-7.82 percent change
Interval -17.33 to 2.78
|
1.87 percent change
Interval -8.53 to 13.45
|
-17.90 percent change
Interval -26.15 to -8.73
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.
C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis.
Outcome measures
| Measure |
MK-5442 2.5 mg
n=49 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=51 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=54 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)
|
-15.39 percent change
Interval -23.8 to -6.05
|
-5.87 percent change
Interval -15.32 to 4.63
|
-4.93 percent change
Interval -14.23 to 5.39
|
5.68 percent change
Interval -4.77 to 17.27
|
19.37 percent change
Interval 7.6 to 32.43
|
-14.89 percent change
Interval -23.24 to -5.64
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.
Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of microgram (μg)/liter (L).
Outcome measures
| Measure |
MK-5442 2.5 mg
n=49 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=51 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=54 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)
|
-0.60 percent change
Interval -6.87 to 6.1
|
0.26 percent change
Interval -6.17 to 7.13
|
4.39 percent change
Interval -2.13 to 11.35
|
17.33 percent change
Interval 9.93 to 25.22
|
13.13 percent change
Interval 6.02 to 20.72
|
-6.05 percent change
Interval -11.92 to 0.2
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: The 'Per Protocol' population was used for this analysis. The Per-Protocol population was defined as a subset population that excluded participants based on critical protocol violations.
Measurement of P1NP appears to be a sensitive marker of bone formation rate in the assessment of osteoporosis.
Outcome measures
| Measure |
MK-5442 2.5 mg
n=49 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=51 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=54 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)
|
-9.97 percent change
Interval -18.46 to -0.59
|
-9.76 percent change
Interval -18.36 to -0.26
|
2.33 percent change
Interval -7.16 to 12.78
|
21.30 percent change
Interval 9.91 to 33.88
|
38.41 percent change
Interval 25.45 to 52.71
|
-18.36 percent change
Interval -25.96 to -9.97
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.
Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL).
Outcome measures
| Measure |
MK-5442 2.5 mg
n=49 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=51 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=54 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=52 Participants
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin
|
-11.61 percent change
Interval -18.19 to -4.5
|
-2.75 percent change
Interval -10.1 to 5.19
|
9.18 percent change
Interval 1.15 to 17.86
|
25.79 percent change
Interval 16.45 to 35.88
|
37.43 percent change
Interval 27.24 to 48.42
|
-15.62 percent change
Interval -21.83 to -8.92
|
Adverse Events
MK-5442 2.5 mg
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
MK-5442 5 mg
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
MK-5442 7.5 mg
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
MK-5442 10 mg
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
MK-5442 15 mg
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-5442 2.5 mg
n=64 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=62 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=64 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=64 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=63 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=63 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/63 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Cardiac disorders
Angina pectoris aggravated
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/63 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Infections and infestations
Cellulitis of leg
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/63 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Injury, poisoning and procedural complications
Coronary stent stenosis
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/63 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Gastrointestinal disorders
External haemorrhoids
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/63 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder carcinoma
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/63 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Cardiac disorders
Ischaemic heart disease
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/63 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Vascular disorders
Postural hypotension
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/63 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Nervous system disorders
Stroke
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
Other adverse events
| Measure |
MK-5442 2.5 mg
n=64 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 5 mg
n=62 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 7.5 mg
n=64 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 10 mg
n=64 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
|
MK-5442 15 mg
n=63 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
|
Placebo
n=63 participants at risk
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.7%
3/64 • Number of events 3 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
3.2%
2/62 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
3.1%
2/64 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
3.1%
2/64 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
4.8%
3/63 • Number of events 3 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
9.5%
6/63 • Number of events 7 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Infections and infestations
Urinary Tract Infection
|
7.8%
5/64 • Number of events 8 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
8.1%
5/62 • Number of events 6 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
3.1%
2/64 • Number of events 3 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
15.6%
10/64 • Number of events 12 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
4.8%
3/63 • Number of events 5 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
9.5%
6/63 • Number of events 6 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Musculoskeletal and connective tissue disorders
Pain in Hip
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
6.5%
4/62 • Number of events 5 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
4.8%
3/63 • Number of events 3 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/63 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Infections and infestations
Chest Infection
|
3.1%
2/64 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/62 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
6.2%
4/64 • Number of events 4 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
3.2%
2/63 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/63 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Infections and infestations
Common Cold
|
6.2%
4/64 • Number of events 4 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
4.8%
3/62 • Number of events 3 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
4.7%
3/64 • Number of events 3 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
7.8%
5/64 • Number of events 5 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/63 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
4.8%
3/63 • Number of events 5 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
2/64 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
6.5%
4/62 • Number of events 4 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
6.2%
4/64 • Number of events 4 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
10.9%
7/64 • Number of events 7 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
7.9%
5/63 • Number of events 5 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
6.3%
4/63 • Number of events 6 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/64 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/62 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
3.1%
2/64 • Number of events 3 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
3.1%
2/64 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
3.2%
2/63 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
7.9%
5/63 • Number of events 5 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
General disorders
Tiredness
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/62 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/64 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
6.3%
4/63 • Number of events 5 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Nervous system disorders
Headache
|
7.8%
5/64 • Number of events 5 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
9.7%
6/62 • Number of events 6 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
3.1%
2/64 • Number of events 3 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
6.2%
4/64 • Number of events 4 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
7.9%
5/63 • Number of events 5 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
7.9%
5/63 • Number of events 6 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
2/64 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
4.8%
3/62 • Number of events 3 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
1.6%
1/64 • Number of events 1 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
6.2%
4/64 • Number of events 4 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
3.2%
2/63 • Number of events 2 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
0.00%
0/63 • From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp and Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or his/her colleagues may publish the results of the study associated with their study site independently.
- Publication restrictions are in place
Restriction type: OTHER