Trial Outcomes & Findings for Confirmatory Study of DSP-5423P in Patients With Schizophrenia (NCT NCT02287584)
NCT ID: NCT02287584
Last Updated: 2022-04-12
Results Overview
The Positive and Negative Syndrome Scale (PANSS) is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
580 participants
Primary outcome timeframe
Week 6
Results posted on
2022-04-12
Participant Flow
Participants were conducted in 8 countries/region between December 2014 and October 2018.
In this study, 675 subjects provided informed consent, 580 of 606 subjects.
Participant milestones
| Measure |
DSP-5423P Placebo
Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 40mg
Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 80mg
Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P Placebo-to-Flex
Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen once daily.
DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day.
|
DSP-5423P 40mg-to-Flex
Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen once daily.
DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day.
|
DSP-5423P 80mg-to-Flex
Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen once daily.
DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day.
|
|---|---|---|---|---|---|---|
|
the Double-blind Phase
STARTED
|
190
|
196
|
194
|
0
|
0
|
0
|
|
the Double-blind Phase
COMPLETED
|
138
|
149
|
161
|
0
|
0
|
0
|
|
the Double-blind Phase
NOT COMPLETED
|
52
|
47
|
33
|
0
|
0
|
0
|
|
the Open-label Phase
STARTED
|
0
|
0
|
0
|
138
|
149
|
161
|
|
the Open-label Phase
Treated
|
0
|
0
|
0
|
131
|
143
|
157
|
|
the Open-label Phase
COMPLETED
|
0
|
0
|
0
|
81
|
87
|
104
|
|
the Open-label Phase
NOT COMPLETED
|
0
|
0
|
0
|
57
|
62
|
57
|
Reasons for withdrawal
| Measure |
DSP-5423P Placebo
Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 40mg
Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 80mg
Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P Placebo-to-Flex
Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen once daily.
DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day.
|
DSP-5423P 40mg-to-Flex
Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen once daily.
DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day.
|
DSP-5423P 80mg-to-Flex
Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen once daily.
DSP-5423P 20 mg patches and DSP-5423P 40 mg patches were used in the open-label treatment phase. One or two patches of DSP-5423P was/were applied once daily to subjects for a further 28 weeks (outside Japan) or 52 weeks (in Japan). The initial dose of DSP-5423P in the open-label treatment phase was 40 mg/day. After DSP-5423P 40 mg/day application for about 1 week, DSP-5423P could be applied as flexible dose within a range from 40 mg/day to 80 mg/day.
|
|---|---|---|---|---|---|---|
|
the Double-blind Phase
Adverse Event
|
17
|
17
|
12
|
0
|
0
|
0
|
|
the Double-blind Phase
Lack of Efficacy
|
18
|
8
|
8
|
0
|
0
|
0
|
|
the Double-blind Phase
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
0
|
|
the Double-blind Phase
Withdrawal by Subject
|
17
|
17
|
11
|
0
|
0
|
0
|
|
the Double-blind Phase
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
0
|
|
the Double-blind Phase
Protocol Violation
|
0
|
3
|
0
|
0
|
0
|
0
|
|
the Double-blind Phase
other reasons
|
0
|
0
|
1
|
0
|
0
|
0
|
|
the Open-label Phase
Did not receive drug
|
0
|
0
|
0
|
7
|
6
|
4
|
|
the Open-label Phase
Adverse Event
|
0
|
0
|
0
|
15
|
12
|
16
|
|
the Open-label Phase
Lack of Efficacy
|
0
|
0
|
0
|
8
|
3
|
7
|
|
the Open-label Phase
Lost to Follow-up
|
0
|
0
|
0
|
4
|
1
|
2
|
|
the Open-label Phase
Withdrawal by Subject
|
0
|
0
|
0
|
18
|
29
|
21
|
|
the Open-label Phase
non-compliance
|
0
|
0
|
0
|
2
|
5
|
1
|
|
the Open-label Phase
other reasons
|
0
|
0
|
0
|
3
|
6
|
6
|
Baseline Characteristics
Confirmatory Study of DSP-5423P in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
DSP-5423P Placebo
n=189 Participants
Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 40mg
n=196 Participants
Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 80mg
n=192 Participants
Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
|
Total
n=577 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 13.67 • n=99 Participants
|
40.7 years
STANDARD_DEVIATION 13.34 • n=107 Participants
|
40.7 years
STANDARD_DEVIATION 14.35 • n=206 Participants
|
41.0 years
STANDARD_DEVIATION 13.77 • n=7 Participants
|
|
Age, Customized
<65
|
176 Participants
n=99 Participants
|
185 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
541 Participants
n=7 Participants
|
|
Age, Customized
>=65
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
234 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
343 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
189 Participants
n=99 Participants
|
196 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
577 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
161 Participants
n=99 Participants
|
167 Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
493 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
84 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
South Korea
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
7 participants
n=206 Participants
|
21 participants
n=7 Participants
|
|
Region of Enrollment
Japan
|
51 participants
n=99 Participants
|
55 participants
n=107 Participants
|
56 participants
n=206 Participants
|
162 participants
n=7 Participants
|
|
Region of Enrollment
Philippines
|
25 participants
n=99 Participants
|
22 participants
n=107 Participants
|
22 participants
n=206 Participants
|
69 participants
n=7 Participants
|
|
Region of Enrollment
China
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
10 participants
n=206 Participants
|
28 participants
n=7 Participants
|
|
Region of Enrollment
Taiwan
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
17 participants
n=206 Participants
|
46 participants
n=7 Participants
|
|
Region of Enrollment
Ukraine
|
14 participants
n=99 Participants
|
17 participants
n=107 Participants
|
15 participants
n=206 Participants
|
46 participants
n=7 Participants
|
|
Region of Enrollment
Malaysia
|
55 participants
n=99 Participants
|
58 participants
n=107 Participants
|
53 participants
n=206 Participants
|
166 participants
n=7 Participants
|
|
Region of Enrollment
Russia
|
14 participants
n=99 Participants
|
13 participants
n=107 Participants
|
12 participants
n=206 Participants
|
39 participants
n=7 Participants
|
|
Positive and Negative Syndrome Scale (PANSS) total score
|
99.5 units on a scale
STANDARD_DEVIATION 13.84 • n=99 Participants
|
101.6 units on a scale
STANDARD_DEVIATION 15.55 • n=107 Participants
|
101.5 units on a scale
STANDARD_DEVIATION 14.76 • n=206 Participants
|
100.9 units on a scale
STANDARD_DEVIATION 14.75 • n=7 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: modified Intention-to-treat (mITT) population; Change in PANSS Total Score Using Mixed Model for Repeated Measures in the Double-Blind Treatment Phase
The Positive and Negative Syndrome Scale (PANSS) is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.
Outcome measures
| Measure |
DSP-5423P Placebo
n=189 Participants
Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 40mg
n=196 Participants
Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 80mg
n=192 Participants
Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
|
|---|---|---|---|
|
Change in PANSS Total Score From Baseline at Week 6
baseline mean(SD)
|
99.5 units on a scale
Standard Error 13.84
|
101.6 units on a scale
Standard Error 15.55
|
101.5 units on a scale
Standard Error 14.76
|
|
Change in PANSS Total Score From Baseline at Week 6
Change at Week 6
|
-10.8 units on a scale
Standard Error 1.47
|
-16.4 units on a scale
Standard Error 1.43
|
-21.3 units on a scale
Standard Error 1.41
|
SECONDARY outcome
Timeframe: Week 6 (LOCF)Population: modified Intention-to-treat (mITT) population
The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and 3 subscales: the Positive subscale assesses hallucinations, delusions, and related symptoms; the Negative subscale assesses emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine a total score. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity. The Last Observation Carried Forward (LOCF) endpoint is defined as the last data captured on Day 1 through 7 days after the final application of DSP-5423P.
Outcome measures
| Measure |
DSP-5423P Placebo
n=189 Participants
Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 40mg
n=196 Participants
Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 80mg
n=192 Participants
Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
|
|---|---|---|---|
|
Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
>=20% improvement from baseline
|
80 Participants
|
99 Participants
|
107 Participants
|
|
Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
>=30% improvement from baseline
|
52 Participants
|
72 Participants
|
80 Participants
|
|
Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
>=40% improvement from baseline
|
32 Participants
|
49 Participants
|
55 Participants
|
|
Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
>=50% improvement from baseline
|
15 Participants
|
25 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Open-Week 28 and Open-Week 52 in the open-label treatment phasePopulation: Open-label population: all subjects who applied DSP-5423P at least once in the open-label treatment phase.
Percentage of subjects who stay the study up to 28 weeks (196 days, all countries), and 52 weeks (364 days, in Japan) and its 95% confidence interval.
Outcome measures
| Measure |
DSP-5423P Placebo
n=131 Participants
Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 40mg
n=143 Participants
Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 80mg
n=157 Participants
Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
|
|---|---|---|---|
|
Treatment Continuation Rate at 28 Weeks and 52 Weeks
52 weeks (364 days, in Japan)
|
44.4 percentage of subjects
Interval 23.4 to 63.6
|
51.5 percentage of subjects
Interval 33.5 to 66.9
|
50.0 percentage of subjects
Interval 34.2 to 63.9
|
|
Treatment Continuation Rate at 28 Weeks and 52 Weeks
28 weeks (196 days, all countries)
|
64.4 percentage of subjects
Interval 55.7 to 72.2
|
62.9 percentage of subjects
Interval 54.5 to 70.3
|
70.7 percentage of subjects
Interval 62.9 to 77.2
|
Adverse Events
DSP-5423P Placebo
Serious events: 9 serious events
Other events: 45 other events
Deaths: 0 deaths
DSP-5423P 40mg
Serious events: 8 serious events
Other events: 62 other events
Deaths: 0 deaths
DSP-5423P 80mg
Serious events: 10 serious events
Other events: 76 other events
Deaths: 1 deaths
DSP-5423P Placebo-to-Flex
Serious events: 18 serious events
Other events: 60 other events
Deaths: 1 deaths
DSP-5423P 40mg-to-Flex
Serious events: 24 serious events
Other events: 108 other events
Deaths: 0 deaths
DSP-5423P 80mg-to-Flex
Serious events: 29 serious events
Other events: 111 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
DSP-5423P Placebo
n=190 participants at risk
Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 40mg
n=196 participants at risk
Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 80mg
n=194 participants at risk
Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P Placebo-to-Flex
n=131 participants at risk
Percutaneous Subjects received DSP-5423P Placebo once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
DSP-5423P Placebo-to-Flex: DSP-5423P Placebo:
DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 40mg-to-Flex
n=196 participants at risk
Percutaneous Subjects received DSP-5423P 40mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
DSP-5423P Active-to-Flex: DSP-5423P Active:
DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 80mg-to-Flex
n=194 participants at risk
Percutaneous Subjects received DSP-5423P 80mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.76%
1/131 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
General disorders
Death
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
General disorders
Sudden death
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.76%
1/131 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.76%
1/131 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
1.0%
2/194 • Number of events 2 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Investigations
Weight increased
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.76%
1/131 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
1.0%
2/196 • Number of events 2 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Nervous system disorders
Loss of consciousness
|
0.53%
1/190 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Catatonia
|
0.53%
1/190 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
1.0%
2/196 • Number of events 3 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Psychotic disorder
|
1.1%
2/190 • Number of events 2 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
3.1%
4/131 • Number of events 4 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
1.0%
2/196 • Number of events 2 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 2 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Schizophrenia
|
2.1%
4/190 • Number of events 4 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
2.0%
4/196 • Number of events 4 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
1.0%
2/194 • Number of events 2 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
6.9%
9/131 • Number of events 9 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.1%
10/196 • Number of events 11 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.2%
10/194 • Number of events 11 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.76%
1/131 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
1.0%
2/196 • Number of events 2 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Social circumstances
Social stay hospitalisation
|
0.53%
1/190 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/194 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/131 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
Other adverse events
| Measure |
DSP-5423P Placebo
n=190 participants at risk
Percutaneous DSP-5423P Placebo was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P Placebo: DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 40mg
n=196 participants at risk
Percutaneous DSP-5423P 40mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 40mg: DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 80mg
n=194 participants at risk
Percutaneous DSP-5423P 80mg was applied once daily for 6 weeks during the double-blinded treatment phase. Subjects who completed the double-blind treatment phase were able to entere the open-label treatment phase. The study drug was applied to the back, chest, or abdomen.
DSP-5423P 80mg: DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P Placebo-to-Flex
n=131 participants at risk
Percutaneous Subjects received DSP-5423P Placebo once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
DSP-5423P Placebo-to-Flex: DSP-5423P Placebo:
DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 40mg-to-Flex
n=196 participants at risk
Percutaneous Subjects received DSP-5423P 40mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
DSP-5423P Active-to-Flex: DSP-5423P Active:
DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily
DSP-5423P Flex:
DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily
|
DSP-5423P 80mg-to-Flex
n=194 participants at risk
Percutaneous Subjects received DSP-5423P 80mg once daily for 6 weeks in the double-blind treatment phase. In the open-label treatment phase, DSP-5423P was applied as flexible dose (40, 60, or 80 mg) once daily for 28 weeks (outside Japan) or 52 weeks (in Japan). The study drug was applied to the back, chest, or abdomen.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.6%
5/190 • Number of events 5 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
4.1%
8/196 • Number of events 9 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
4.1%
8/194 • Number of events 9 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
4.6%
6/131 • Number of events 8 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
4.1%
8/196 • Number of events 11 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
6.7%
13/194 • Number of events 18 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.53%
1/190 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.00%
0/196 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
2.1%
4/194 • Number of events 4 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
2.3%
3/131 • Number of events 3 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
2.6%
5/196 • Number of events 6 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.2%
10/194 • Number of events 12 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
General disorders
Application site erythema
|
1.6%
3/190 • Number of events 4 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.6%
11/196 • Number of events 17 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
9.3%
18/194 • Number of events 33 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
6.1%
8/131 • Number of events 12 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
6.1%
12/196 • Number of events 22 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
11.9%
23/194 • Number of events 43 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
General disorders
Application site pruritus
|
0.53%
1/190 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.1%
10/196 • Number of events 11 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
7.2%
14/194 • Number of events 14 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
3.1%
4/131 • Number of events 5 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
7.1%
14/196 • Number of events 15 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
9.8%
19/194 • Number of events 20 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
8/190 • Number of events 8 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
2.6%
5/196 • Number of events 8 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
4.6%
9/194 • Number of events 9 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
8.4%
11/131 • Number of events 11 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
7.1%
14/196 • Number of events 27 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
12.9%
25/194 • Number of events 32 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.53%
1/190 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
2.0%
4/196 • Number of events 6 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
1.5%
3/194 • Number of events 3 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.3%
7/131 • Number of events 10 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.6%
11/196 • Number of events 14 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
2.6%
5/194 • Number of events 7 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Investigations
Weight increased
|
3.2%
6/190 • Number of events 6 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
1.5%
3/196 • Number of events 3 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
1.5%
3/194 • Number of events 3 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
12.2%
16/131 • Number of events 16 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
6.6%
13/196 • Number of events 13 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
6.7%
13/194 • Number of events 13 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
1.5%
3/196 • Number of events 3 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
3.6%
7/194 • Number of events 7 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
3.1%
4/131 • Number of events 4 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
2.6%
5/196 • Number of events 6 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.7%
11/194 • Number of events 12 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Nervous system disorders
Akathisia
|
1.1%
2/190 • Number of events 2 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.6%
11/196 • Number of events 11 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
9.8%
19/194 • Number of events 22 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
8.4%
11/131 • Number of events 14 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
11.2%
22/196 • Number of events 27 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
13.9%
27/194 • Number of events 34 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Nervous system disorders
Bradykinesia
|
0.00%
0/190 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.51%
1/196 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
3.1%
6/194 • Number of events 6 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.76%
1/131 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
3.1%
6/196 • Number of events 6 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.7%
11/194 • Number of events 11 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Nervous system disorders
Headache
|
2.6%
5/190 • Number of events 5 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
4.6%
9/196 • Number of events 10 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
3.6%
7/194 • Number of events 7 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
4.6%
6/131 • Number of events 6 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
6.6%
13/196 • Number of events 21 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
8.8%
17/194 • Number of events 35 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Nervous system disorders
Tremor
|
2.6%
5/190 • Number of events 5 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
4.1%
8/196 • Number of events 9 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
8.8%
17/194 • Number of events 18 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
6.9%
9/131 • Number of events 9 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
7.1%
14/196 • Number of events 15 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
13.9%
27/194 • Number of events 33 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Insomnia
|
4.7%
9/190 • Number of events 10 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.1%
10/196 • Number of events 12 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
5.2%
10/194 • Number of events 11 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
3.8%
5/131 • Number of events 28 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
11.2%
22/196 • Number of events 32 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
10.3%
20/194 • Number of events 29 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
|
Psychiatric disorders
Schizophrenia
|
5.3%
10/190 • Number of events 10 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
3.1%
6/196 • Number of events 6 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
0.52%
1/194 • Number of events 1 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
2.3%
3/131 • Number of events 3 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
6.6%
13/196 • Number of events 13 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
2.6%
5/194 • Number of events 5 • Up to 58 weeks
Safety population in the double-blind phase; The safety population consisted of all subjects who were randomized and applied the study drug at least once during the study. DSP-5423P dosed population in the open-label population; The DSP-5423P dosed population consisted of all subjects who applied DSP-5423P at least once during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place