Trial Outcomes & Findings for Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder (NCT NCT01491035)
NCT ID: NCT01491035
Last Updated: 2017-03-16
Results Overview
Maximum plasma concentration of vortioxetine
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level
Results posted on
2017-03-16
Participant Flow
Participant milestones
| Measure |
Adolescents, 5 mg
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Adolescents, 10 mg
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Adolescents, 15 mg
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Adolescents, 20 mg
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Children, 5 mg
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Children, 10 mg
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Children, 15 mg
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Children, 20 mg
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
5
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Adolescents, 5 mg
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Adolescents, 10 mg
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Adolescents, 15 mg
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Adolescents, 20 mg
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Children, 5 mg
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Children, 10 mg
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Children, 15 mg
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Children, 20 mg
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Adolescents, 5 mg
n=6 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Adolescents, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Adolescents, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Adolescents, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Children, 5 mg
n=6 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Children, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Children, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Children, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
15.7 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
15.3 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
15.2 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
14.8 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
10.3 years
STANDARD_DEVIATION 1.2 • n=21 Participants
|
9.7 years
STANDARD_DEVIATION 1.2 • n=10 Participants
|
10.5 years
STANDARD_DEVIATION 0.8 • n=115 Participants
|
9.8 years
STANDARD_DEVIATION 1.8 • n=6 Participants
|
12.7 years
STANDARD_DEVIATION 3.0 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
25 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
23 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
16 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
29 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
6 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=6 Participants
|
43 participants
n=6 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=6 Participants
|
5 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose levelPopulation: Pharmacokinetic analysis set = all patients who took at least one dose of IMP and who contributed with both Day 1 pre-dose pharmacokinetic sampling data and sufficient post-dose sampling data for estimation of the pharmacokinetic parameters.
Maximum plasma concentration of vortioxetine
Outcome measures
| Measure |
Adolescents, 5 mg
n=5 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Adolescents, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Adolescents, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Adolescents, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Children, 5 mg
n=6 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Children, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Children, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Children, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
|---|---|---|---|---|---|---|---|---|
|
Cmax of Vortioxetine
|
4.3 ng/mL
Standard Deviation 3.7
|
7.8 ng/mL
Standard Deviation 2.8
|
15 ng/mL
Standard Deviation 6.2
|
16 ng/mL
Standard Deviation 8.1
|
5.0 ng/mL
Standard Deviation 3.3
|
14 ng/mL
Standard Deviation 8.2
|
26 ng/mL
Standard Deviation 21
|
31 ng/mL
Standard Deviation 20
|
PRIMARY outcome
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose levelPopulation: Pharmacokinetic analysis set
Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours
Outcome measures
| Measure |
Adolescents, 5 mg
n=5 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Adolescents, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Adolescents, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Adolescents, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Children, 5 mg
n=6 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Children, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Children, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Children, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
|---|---|---|---|---|---|---|---|---|
|
AUC(0-24h) of Vortioxetine
|
82 ng*h/mL
Standard Deviation 71
|
144 ng*h/mL
Standard Deviation 60
|
283 ng*h/mL
Standard Deviation 115
|
304 ng*h/mL
Standard Deviation 143
|
89 ng*h/mL
Standard Deviation 66
|
261 ng*h/mL
Standard Deviation 137
|
492 ng*h/mL
Standard Deviation 373
|
562 ng*h/mL
Standard Deviation 374
|
PRIMARY outcome
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose levelPopulation: Pharmacokinetic analysis set
Half-life of vortioxetine in plasma
Outcome measures
| Measure |
Adolescents, 5 mg
n=5 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Adolescents, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Adolescents, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Adolescents, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Children, 5 mg
n=6 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Children, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Children, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Children, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
|---|---|---|---|---|---|---|---|---|
|
t½ of Vortioxetine
|
46 h
Standard Deviation 33
|
56 h
Standard Deviation 19
|
50 h
Standard Deviation 16
|
40 h
Standard Deviation 10
|
45 h
Standard Deviation 27
|
52 h
Standard Deviation 18
|
71 h
Standard Deviation 52
|
62 h
Standard Deviation 23
|
PRIMARY outcome
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose levelPopulation: Pharmacokinetic analysis set
Maximum plasma concentration of the major, inactive metabolite Lu AA34443
Outcome measures
| Measure |
Adolescents, 5 mg
n=5 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Adolescents, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Adolescents, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Adolescents, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Children, 5 mg
n=6 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Children, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Children, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Children, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
|---|---|---|---|---|---|---|---|---|
|
Cmax of Lu AA34443
|
3.5 ng/mL
Standard Deviation 2.2
|
14 ng/mL
Standard Deviation 7.1
|
16 ng/mL
Standard Deviation 5.3
|
38 ng/mL
Standard Deviation 12
|
7.8 ng/mL
Standard Deviation 3.4
|
15 ng/mL
Standard Deviation 5.4
|
20 ng/mL
Standard Deviation 13
|
47 ng/mL
Standard Deviation 17
|
PRIMARY outcome
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose levelPopulation: Pharmacokinetic analysis set
Area under the plasma concentration-time curve from 0 to 24 hours for the major, inactive metabolite Lu AA34443
Outcome measures
| Measure |
Adolescents, 5 mg
n=5 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Adolescents, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Adolescents, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Adolescents, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Children, 5 mg
n=6 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Children, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Children, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Children, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
|---|---|---|---|---|---|---|---|---|
|
AUC(0-24h) of Lu AA34443
|
56 ng*h/mL
Standard Deviation 29
|
223 ng*h/mL
Standard Deviation 98
|
266 ng*h/mL
Standard Deviation 100
|
544 ng*h/mL
Standard Deviation 192
|
115 ng*h/mL
Standard Deviation 47
|
241 ng*h/mL
Standard Deviation 93
|
429 ng*h/mL
Standard Deviation 232
|
646 ng*h/mL
Standard Deviation 251
|
PRIMARY outcome
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose levelPopulation: Pharmacokinetic analysis set
Half-life of the major, inactive metabolite Lu AA34443 in plasma
Outcome measures
| Measure |
Adolescents, 5 mg
n=5 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Adolescents, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Adolescents, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Adolescents, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Children, 5 mg
n=6 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Children, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Children, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Children, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
|---|---|---|---|---|---|---|---|---|
|
t½ of Lu AA34443
|
26 h
Standard Deviation 9.3
|
33 h
Standard Deviation 13
|
24 h
Standard Deviation 11
|
24 h
Standard Deviation 5.1
|
20 h
Standard Deviation 24
|
19 h
Standard Deviation 9.6
|
29 h
Standard Deviation 6.1
|
27 h
Standard Deviation 8.8
|
PRIMARY outcome
Timeframe: Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose levelPopulation: Pharmacokinetic analysis set
Oral clearance expressed as a function of bioavailability
Outcome measures
| Measure |
Adolescents, 5 mg
n=5 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Adolescents, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Adolescents, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Adolescents, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Children, 5 mg
n=6 Participants
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Children, 10 mg
n=6 Participants
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Children, 15 mg
n=6 Participants
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Children, 20 mg
n=6 Participants
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
|---|---|---|---|---|---|---|---|---|
|
Oral Clearance (CL/F) of Vortioxetine
|
60 L/h
Standard Deviation 55
|
50 L/h
Standard Deviation 16
|
50 L/h
Standard Deviation 23
|
61 L/h
Standard Deviation 20
|
50 L/h
Standard Deviation 16
|
42 L/h
Standard Deviation 25
|
29 L/h
Standard Deviation 33
|
34 L/h
Standard Deviation 17
|
Adverse Events
Adolescents, 5 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Adolescents, 10 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Adolescents, 15 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Adolescents, 20 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Children, 5 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Children, 10 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Children, 15 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Children, 20 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adolescents, 5 mg
n=6 participants at risk
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Adolescents, 10 mg
n=6 participants at risk
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Adolescents, 15 mg
n=6 participants at risk
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Adolescents, 20 mg
n=6 participants at risk
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
Children, 5 mg
n=6 participants at risk
Vortioxetine: 5 mg tablets for 14 days; orally; once daily
|
Children, 10 mg
n=6 participants at risk
Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
|
Children, 15 mg
n=6 participants at risk
Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
|
Children, 20 mg
n=6 participants at risk
Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
50.0%
3/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
50.0%
3/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
50.0%
3/6 • 4 to 5 weeks, depending on the assigned dose
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
50.0%
3/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
General disorders
Chills
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
General disorders
Fatigue
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
General disorders
Infusion site pain
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
General disorders
Irritability
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
|
General disorders
Pyrexia
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Investigations
White blood cells urine positive
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Metabolism and nutrition disorders
Pica
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Nervous system disorders
Akathisia
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Nervous system disorders
Psychomotor hyperactivity
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Nervous system disorders
Sedation
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
50.0%
3/6 • 4 to 5 weeks, depending on the assigned dose
|
33.3%
2/6 • 4 to 5 weeks, depending on the assigned dose
|
50.0%
3/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Psychiatric disorders
Frustration
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Psychiatric disorders
Hostility
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Psychiatric disorders
Initial insomnia
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
0.00%
0/6 • 4 to 5 weeks, depending on the assigned dose
|
16.7%
1/6 • 4 to 5 weeks, depending on the assigned dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place