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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142688 | Registry Identifier | JAPIC Clinical Trials Informaton |
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The primary objective of the study is to evaluate the efficacy of DSP-5423P compared with placebo in patients with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSP-5423P Placebo | Placebo Comparator | 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 40mg | Experimental | 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 80mg | Experimental | 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 Placebo-to-Flex | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSP-5423P Placebo | Drug | DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in PANSS Total Score From Baseline at Week 6 | 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. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director, Drug Development Division | Sumitomo Pharma Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3 Sites | Beijing, Etc. | China | ||||
| 53 Sites |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39428614 | Derived | Takekita Y, Matsumoto Y, Masuda T, Yoshida K, Koshikawa Y, Kato M. Association between treatment response and dose of blonanserin transdermal patch in patients with acute schizophrenia: A post hoc cluster analysis based on baseline psychiatric symptoms. Neuropsychopharmacol Rep. 2024 Dec;44(4):784-791. doi: 10.1002/npr2.12490. Epub 2024 Oct 20. |
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In this study, 675 subjects provided informed consent, 580 of 606 subjects.
Participants were conducted in 8 countries/region between December 2014 and October 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| the Double-blind Phase |
|
| ||||||||||||||||||
| the Open-label Phase |
|
modified Intention-to-treat (mITT) population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in PANSS Total Score From Baseline at Week 6 | 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. | modified Intention-to-treat (mITT) population; Change in PANSS Total Score Using Mixed Model for Repeated Measures in the Double-Blind Treatment Phase | Posted | Mean | Standard Error | units on a scale | Week 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 19. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 19. | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research | Sumitomo Dainippon Pharmaceutical | +81-3-5159-2519 | cc@ds-pharma.co.jp |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2018 | Aug 31, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 10, 2018 | Aug 31, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DSP-5423P Active-to-Flex | Experimental | Percutaneous Subjects received DSP-5423P 40mg or 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. |
|
| DSP-5423P 40mg | Drug | DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily |
|
| DSP-5423P 80mg | Drug | DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily |
|
| DSP-5423P Placebo-to-Flex | Drug | 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 Active-to-Flex | Drug | 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 |
|
| Week 6 (LOCF) |
| Treatment Continuation Rate at 28 Weeks and 52 Weeks | 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. | Open-Week 28 and Open-Week 52 in the open-label treatment phase |
| Tokyo Etc. |
| Japan |
| 14 Sites | Kuala Lumpur, Etc. | Malaysia |
| 9 Sites | Manila, Etc. | Philippines |
| 8 Sites | Smolensk, Etc | Russia |
| 7 Sites | Seoul, Etc. | South Korea |
| 6 Sites | Taipei, Etc. | Taiwan |
| 8 Sites | Poltava, Etc | Ukraine |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Pregnancy |
|
| Protocol Violation |
|
| other reasons |
|
| Treated | Subjects treated in the open-label treatment phase |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Positive and Negative Syndrome Scale (PANSS) total score | The PANSS 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 to 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 | Mean | Standard Deviation | units on a scale |
|
| Title |
|---|
| Description |
|---|
| OG000 | 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 |
| OG001 | 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 |
| OG002 | 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 |
|
|
|
| Secondary | 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 | 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. | modified Intention-to-treat (mITT) population | Posted | Count of Participants | Participants | Week 6 (LOCF) |
|
|
|
| Secondary | Treatment Continuation Rate at 28 Weeks and 52 Weeks | 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. | Open-label population: all subjects who applied DSP-5423P at least once in the open-label treatment phase. | Posted | Number | 95% Confidence Interval | percentage of subjects | Open-Week 28 and Open-Week 52 in the open-label treatment phase |
|
|
|
| 0 |
| 190 |
| 9 |
| 190 |
| 45 |
| 190 |
| EG001 | 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 | 0 | 196 | 8 | 196 | 62 | 196 |
| EG002 | 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 | 1 | 194 | 10 | 194 | 76 | 194 |
| EG003 | DSP-5423P Placebo-to-Flex | 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 | 1 | 131 | 18 | 131 | 60 | 131 |
| EG004 | DSP-5423P 40mg-to-Flex | 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 | 0 | 196 | 24 | 196 | 108 | 196 |
| EG005 | DSP-5423P 80mg-to-Flex | 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. | 4 | 194 | 29 | 194 | 111 | 194 |
| Colitis | Gastrointestinal disorders | MedDRA Version 19. | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 19. | Systematic Assessment |
|
| Death | General disorders | MedDRA Version 19. | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA Version 19. | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA Version 19. | Systematic Assessment |
|
| Bartholin's abscess | Infections and infestations | MedDRA Version 19. | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA Version 19. | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 19. | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA Version 19. | Systematic Assessment |
|
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA Version 19. | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 19. | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA Version 19. | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA Version 19. | Systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA Version 19. | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA Version 19. | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 19. | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA Version 19. | Systematic Assessment |
|
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA Version 19. | Systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | MedDRA Version 19. | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA Version 19. | Systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
| Catatonia | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
| Psychiatric symptom | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19. | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19. | Systematic Assessment |
|
| Social stay hospitalisation | Social circumstances | MedDRA Version 19. | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 19. | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA Version 19. | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA Version 19. | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA Version 19. | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 19. | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 19. | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA Version 19. | Systematic Assessment |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA Version 19. | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA Version 19. | Systematic Assessment |
|
| Bradykinesia | Nervous system disorders | MedDRA Version 19. | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 19. | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Version 19. | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA Version 19. | Systematic Assessment |
|
Not provided
Not provided
|
| >=40% improvement from baseline |
|
| >=50% improvement from baseline |
|
| 52 weeks (364 days, in Japan) |
|
|