Trial Outcomes & Findings for Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675) (NCT NCT00941603)
NCT ID: NCT00941603
Last Updated: 2018-09-25
Results Overview
The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
619 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2018-09-25
Participant Flow
Participant milestones
| Measure |
SCH 900271 15 mg
Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 10 mg
Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 5 mg
Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 2.5 mg
Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 1 mg
Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
Placebo
Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
104
|
105
|
104
|
104
|
105
|
97
|
|
Overall Study
COMPLETED
|
93
|
89
|
99
|
100
|
101
|
94
|
|
Overall Study
NOT COMPLETED
|
11
|
16
|
5
|
4
|
4
|
3
|
Reasons for withdrawal
| Measure |
SCH 900271 15 mg
Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 10 mg
Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 5 mg
Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 2.5 mg
Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 1 mg
Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
Placebo
Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
15
|
5
|
1
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Did not meet protocol eligibility
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
Baseline characteristics by cohort
| Measure |
SCH 900271 15 mg
n=104 Participants
Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 10 mg
n=105 Participants
Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 5 mg
n=104 Participants
Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 2.5 mg
n=104 Participants
Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 1 mg
n=105 Participants
Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
Placebo
n=97 Participants
Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
|
Total
n=619 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.5 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
56.0 Years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
56.1 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
56.5 Years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
57.5 Years
STANDARD_DEVIATION 9.4 • n=21 Participants
|
55.2 Years
STANDARD_DEVIATION 9.5 • n=8 Participants
|
56.5 Years
STANDARD_DEVIATION 9.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
300 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
319 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Intent-to-treat population defined as all participants who receive randomized treatment assignment, and have a baseline and at least one post-baseline LDL-C determination.
The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.
Outcome measures
| Measure |
SCH 900271 15 mg
n=102 Participants
Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 10 mg
n=105 Participants
Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 5 mg
n=103 Participants
Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 2.5 mg
n=101 Participants
Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 1 mg
n=105 Participants
Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
Placebo
n=96 Participants
Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Direct LDL-C at Week 8
|
-2.0 Percent change
Standard Error 1.3
|
-1.5 Percent change
Standard Error 1.3
|
-4.2 Percent change
Standard Error 1.3
|
0.2 Percent change
Standard Error 1.3
|
1.2 Percent change
Standard Error 1.3
|
1.5 Percent change
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Intent-to-treat population defined as all participants who receive randomized treatment assignment and have a baseline and at least one post-baseline non-HDL-C determination.
The percentage change from baseline in the participants' non-HDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.
Outcome measures
| Measure |
SCH 900271 15 mg
n=102 Participants
Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 10 mg
n=105 Participants
Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 5 mg
n=104 Participants
Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 2.5 mg
n=102 Participants
Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 1 mg
n=105 Participants
Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
Placebo
n=97 Participants
Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Direct Non-HDL-C at Week 8
|
-2.1 Percent change
Standard Error 1.2
|
-2.7 Percent change
Standard Error 1.2
|
-3.5 Percent change
Standard Error 1.2
|
-0.5 Percent change
Standard Error 1.3
|
1.6 Percent change
Standard Error 1.2
|
0.9 Percent change
Standard Error 1.3
|
Adverse Events
SCH 900271 15 mg
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
SCH 900271 10 mg
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
SCH 900271 5 mg
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
SCH 900271 2.5 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SCH 900271 1 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SCH 900271 15 mg
n=103 participants at risk
Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 10 mg
n=105 participants at risk
Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 5 mg
n=104 participants at risk
Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 2.5 mg
n=104 participants at risk
Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 1 mg
n=105 participants at risk
Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
Placebo
n=97 participants at risk
Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.97%
1/103 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.97%
1/103 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
General disorders
Chest pain
|
0.97%
1/103 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
General disorders
Tenderness
|
0.00%
0/103 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.95%
1/105 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/103 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.95%
1/105 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/103 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.95%
1/105 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/103 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.95%
1/105 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Infections and infestations
Diverticulitis
|
0.97%
1/103 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.96%
1/104 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.97%
1/103 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.97%
1/103 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.97%
1/103 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/103 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.95%
1/105 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/103 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.95%
1/105 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/103 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.96%
1/104 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.97%
1/103 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/103 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.96%
1/104 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
Other adverse events
| Measure |
SCH 900271 15 mg
n=103 participants at risk
Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 10 mg
n=105 participants at risk
Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 5 mg
n=104 participants at risk
Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 2.5 mg
n=104 participants at risk
Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
SCH 900271 1 mg
n=105 participants at risk
Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
|
Placebo
n=97 participants at risk
Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.97%
1/103 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
5.7%
6/105 • Number of events 6 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
1.9%
2/104 • Number of events 2 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/104 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/105 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.97%
1/103 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
5.7%
6/105 • Number of events 7 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.96%
1/104 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.96%
1/104 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.95%
1/105 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.5%
18/103 • Number of events 20 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
20.0%
21/105 • Number of events 24 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
7.7%
8/104 • Number of events 9 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
1.9%
2/104 • Number of events 2 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
2.9%
3/105 • Number of events 3 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Nausea
|
16.5%
17/103 • Number of events 18 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
17.1%
18/105 • Number of events 21 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
6.7%
7/104 • Number of events 7 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
1.9%
2/104 • Number of events 2 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
1.9%
2/105 • Number of events 2 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
1.0%
1/97 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
5/103 • Number of events 5 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
6.7%
7/105 • Number of events 8 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
1.9%
2/104 • Number of events 2 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.96%
1/104 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.95%
1/105 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.00%
0/97 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
6/103 • Number of events 6 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
4.8%
5/105 • Number of events 6 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
5.8%
6/104 • Number of events 7 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
2.9%
3/104 • Number of events 3 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
2.9%
3/105 • Number of events 3 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
2.1%
2/97 • Number of events 2 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
|
Vascular disorders
Flushing
|
17.5%
18/103 • Number of events 19 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
13.3%
14/105 • Number of events 14 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
2.9%
3/104 • Number of events 3 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
0.96%
1/104 • Number of events 1 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
4.8%
5/105 • Number of events 6 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
2.1%
2/97 • Number of events 2 • up to approximately 96 days (including 30 days following last dose for serious adverse events)
Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER