Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1) (NCT NCT01206517)
NCT ID: NCT01206517
Last Updated: 2024-05-23
Results Overview
Cmax is the peak plasma concentration following a dose of the study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)
Results posted on
2024-05-23
Participant Flow
Participant milestones
| Measure |
Asenapine 2.5 mg - Cohort 1
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
|
Asenapine 5 mg - Cohort 2
Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
|
Asenapine 10 mg - Cohort 3a
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
|
Asenapine 10 mg - Cohort 3b
Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3c
Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3d
Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
6
|
6
|
4
|
4
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Asenapine 2.5 mg - Cohort 1
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
|
Asenapine 5 mg - Cohort 2
Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
|
Asenapine 10 mg - Cohort 3a
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
|
Asenapine 10 mg - Cohort 3b
Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3c
Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3d
Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)
Baseline characteristics by cohort
| Measure |
Asenapine 2.5 mg - Cohort 1
n=6 Participants
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
|
Asenapine 5 mg - Cohort 2
n=6 Participants
Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
|
Asenapine 10 mg - Cohort 3a
n=6 Participants
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
|
Asenapine 10 mg - Cohort 3b
n=4 Participants
Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3c
n=4 Participants
Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3d
n=4 Participants
Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
10.8 years
STANDARD_DEVIATION 0.4 • n=5 Participants
|
10.5 years
STANDARD_DEVIATION 0.8 • n=7 Participants
|
10.3 years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
12.5 years
STANDARD_DEVIATION 0.6 • n=4 Participants
|
14.5 years
STANDARD_DEVIATION 0.6 • n=21 Participants
|
16.5 years
STANDARD_DEVIATION 0.6 • n=10 Participants
|
12.1 years
STANDARD_DEVIATION 2.3 • n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)Population: All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.
Cmax is the peak plasma concentration following a dose of the study drug.
Outcome measures
| Measure |
Asenapine 2.5 mg - Cohort 1
n=6 Participants
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
|
Asenapine 5 mg - Cohort 2
n=6 Participants
Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
|
Asenapine 10 mg - Cohort 3a
n=4 Participants
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
|
Asenapine 10 mg - Cohort 3b
n=4 Participants
Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3c
n=3 Participants
Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3d
n=4 Participants
Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Asenapine
|
1.84 ng/mL
Standard Deviation 1.17
|
3.48 ng/mL
Standard Deviation 0.629
|
9.24 ng/mL
Standard Deviation 5.17
|
6.75 ng/mL
Standard Deviation 0.701
|
6.98 ng/mL
Standard Deviation 6.46
|
7.87 ng/mL
Standard Deviation 2.68
|
PRIMARY outcome
Timeframe: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)Population: All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.
tmax is the time from dosing to maximum plasma drug concentration levels.
Outcome measures
| Measure |
Asenapine 2.5 mg - Cohort 1
n=6 Participants
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
|
Asenapine 5 mg - Cohort 2
n=6 Participants
Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
|
Asenapine 10 mg - Cohort 3a
n=4 Participants
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
|
Asenapine 10 mg - Cohort 3b
n=4 Participants
Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3c
n=3 Participants
Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3d
n=4 Participants
Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Asenapine
|
1.0 hr
Interval 0.5 to 2.0
|
1.8 hr
Interval 1.5 to 3.0
|
1.5 hr
Interval 0.5 to 1.5
|
1.0 hr
Interval 1.0 to 1.0
|
0.5 hr
Interval 0.5 to 3.0
|
1.0 hr
Interval 0.5 to 1.5
|
PRIMARY outcome
Timeframe: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6 and 12 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)Population: All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.
AUC0-12 is the area under the plasma drug-concentration time curve calculated for the 12 hour interval after dosing.
Outcome measures
| Measure |
Asenapine 2.5 mg - Cohort 1
n=6 Participants
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
|
Asenapine 5 mg - Cohort 2
n=6 Participants
Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
|
Asenapine 10 mg - Cohort 3a
n=4 Participants
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
|
Asenapine 10 mg - Cohort 3b
n=4 Participants
Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3c
n=3 Participants
Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3d
n=4 Participants
Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post Dose (AUC0-12) of Asenapine
|
11.4 hr*ng/mL
Standard Deviation 6.10
|
23.6 hr*ng/mL
Standard Deviation 4.02
|
55.2 hr*ng/mL
Standard Deviation 20.9
|
41.3 hr*ng/mL
Standard Deviation 9.59
|
36.5 hr*ng/mL
Standard Deviation 36.7
|
41.8 hr*ng/mL
Standard Deviation 12.6
|
PRIMARY outcome
Timeframe: Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)Population: All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.
Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase.
Outcome measures
| Measure |
Asenapine 2.5 mg - Cohort 1
n=6 Participants
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
|
Asenapine 5 mg - Cohort 2
n=6 Participants
Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
|
Asenapine 10 mg - Cohort 3a
n=4 Participants
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
|
Asenapine 10 mg - Cohort 3b
n=4 Participants
Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3c
n=3 Participants
Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
Asenapine 10 mg - Cohort 3d
n=4 Participants
Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
|---|---|---|---|---|---|---|
|
Terminal Phase (Elimination) Half-life (t1/2) of Asenapine
|
22.0 hr
Standard Deviation 6.12
|
18.5 hr
Standard Deviation 3.11
|
15.9 hr
Standard Deviation 2.34
|
16.5 hr
Standard Deviation 3.38
|
24.3 hr
Standard Deviation 14.9
|
24.6 hr
Standard Deviation 11.1
|
Adverse Events
Asenapine 2.5 mg - Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Asenapine 5 mg - Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Asenapine 10 mg - Cohort 3a-d
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Asenapine 2.5 mg - Cohort 1
n=6 participants at risk
Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
|
Asenapine 5 mg - Cohort 2
n=6 participants at risk
Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
|
Asenapine 10 mg - Cohort 3a-d
n=18 participants at risk
Participants 10-17 years of age:
Participants 10 or 11 years of age (Cohort 3a); administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
Participants 12-17 years of age (Cohort 3b-d); administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to Day 14
|
0.00%
0/6 • Up to Day 14
|
5.6%
1/18 • Number of events 1 • Up to Day 14
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Up to Day 14
|
0.00%
0/6 • Up to Day 14
|
5.6%
1/18 • Number of events 1 • Up to Day 14
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
16.7%
1/6 • Number of events 1 • Up to Day 14
|
0.00%
0/6 • Up to Day 14
|
50.0%
9/18 • Number of events 80 • Up to Day 14
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to Day 14
|
33.3%
2/6 • Number of events 2 • Up to Day 14
|
11.1%
2/18 • Number of events 2 • Up to Day 14
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
0.00%
0/6 • Up to Day 14
|
33.3%
2/6 • Number of events 2 • Up to Day 14
|
0.00%
0/18 • Up to Day 14
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to Day 14
|
33.3%
2/6 • Number of events 2 • Up to Day 14
|
0.00%
0/18 • Up to Day 14
|
|
General disorders
Chest Pain
|
0.00%
0/6 • Up to Day 14
|
0.00%
0/6 • Up to Day 14
|
5.6%
1/18 • Number of events 2 • Up to Day 14
|
|
Investigations
Heart Rate Increased
|
0.00%
0/6 • Up to Day 14
|
0.00%
0/6 • Up to Day 14
|
5.6%
1/18 • Number of events 1 • Up to Day 14
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/6 • Up to Day 14
|
0.00%
0/6 • Up to Day 14
|
5.6%
1/18 • Number of events 1 • Up to Day 14
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to Day 14
|
33.3%
2/6 • Number of events 2 • Up to Day 14
|
38.9%
7/18 • Number of events 8 • Up to Day 14
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 9 • Up to Day 14
|
0.00%
0/6 • Up to Day 14
|
38.9%
7/18 • Number of events 37 • Up to Day 14
|
|
Nervous system disorders
Dystonia
|
0.00%
0/6 • Up to Day 14
|
66.7%
4/6 • Number of events 5 • Up to Day 14
|
16.7%
3/18 • Number of events 3 • Up to Day 14
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to Day 14
|
16.7%
1/6 • Number of events 2 • Up to Day 14
|
11.1%
2/18 • Number of events 4 • Up to Day 14
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Up to Day 14
|
0.00%
0/6 • Up to Day 14
|
5.6%
1/18 • Number of events 1 • Up to Day 14
|
|
Nervous system disorders
Sedation
|
33.3%
2/6 • Number of events 2 • Up to Day 14
|
33.3%
2/6 • Number of events 2 • Up to Day 14
|
5.6%
1/18 • Number of events 2 • Up to Day 14
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Number of events 4 • Up to Day 14
|
0.00%
0/6 • Up to Day 14
|
38.9%
7/18 • Number of events 21 • Up to Day 14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up to Day 14
|
0.00%
0/6 • Up to Day 14
|
5.6%
1/18 • Number of events 1 • Up to Day 14
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/6 • Up to Day 14
|
0.00%
0/6 • Up to Day 14
|
5.6%
1/18 • Number of events 1 • Up to Day 14
|
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 Investigator may not publish/publicly present interim results without prior consent of Sponsor. Any materials that report results of the study must be sent to Sponsor 45 days prior to submission for publication/presentation. Sponsor has right to review and comment. In case of any disagreements concerning appropriateness of the materials, investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues or disagreement, prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER