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This trial is a 52-week study to assess the safety of long-term use of brexpiprazole as adjunctive therapy in combination with an antidepressant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brexpiprazole | Experimental | 2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole | Drug | 2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) | A treatment-emergent adverse event (TEAE) was defined as an AE that started after start of investigational medicinal product (IMP) treatment. | From baseline to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Changes From Baseline in Montgomery Ã…sberg Depression Rating Scale(MADRS) Total Scores at Week 52(LOCF) | The MADRS was a clinician-rated scale which evaluated the level of depression.The MADRS consists of 10 items assessed apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item was scored from 0 to 6, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 60, with higher scores indicating worse condition. |
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Inclusion Criteria:
Rollover subjects
New subjects
Exclusion Criteria:
Rollover subjects
New subjects
Sexually active male subjects who will not agree to practice 2different methods of birth control or to remain abstinent during the trial and for 30 days after the final IMP administration. For birth control, 2 of the following methods must be used: vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide.
Patients with a treatment history showing that all antidepressants (also including those not used for the current major depressive episode) cannot be tolerated
Patients with a history of electroconvulsive therapy
Patients with a diagnosis of any of the following diseases according to DSM-5
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanko-kokorono clinic | Shirakawa | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39424742 | Derived | Kato M, Shiosakai M, Kuwahara K, Iba K, Shimada Y, Saito M, Sekine D, Aoki K, Shiomi Y, Higuchi T. A Multicenter, Open-Label Study to Evaluate the Long-term Safety and Efficacy of Adjunctive Brexpiprazole 2 mg Daily in Japanese Patients with Major Depressive Disorder. CNS Drugs. 2024 Dec;38(12):1003-1016. doi: 10.1007/s40263-024-01124-w. Epub 2024 Oct 18. |
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Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
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This trial was conducted in 248 participants in Japan. Of the 248 subjects who were administered investigational medicinal product, the efficacy analysis set and the safety analysis set comprised 247 subjects (216 rollover subjects, 31 newly enrolled subjects) of the total brexpiprazole population.
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| ID | Title | Description |
|---|---|---|
| FG000 | New Subjects | Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily. |
| FG001 | Rollover Subjects | Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This trial was conducted in 248 participants in Japan. Of the 248 subjects who were administered investigational medicinal product, the efficacy analysis set and the safety analysis set comprised 247 subjects (216 rollover subjects, 31 newly enrolled subjects) of the total brexpiprazole population.
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| ID | Title | Description |
|---|---|---|
| BG000 | New Subjects | Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily. |
| BG001 | Rollover Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) | A treatment-emergent adverse event (TEAE) was defined as an AE that started after start of investigational medicinal product (IMP) treatment. | The safety analysis set comprised subjects who have received at least 1 dose of the IMP. | Posted | Number | percentage of participants | From baseline to week 52 |
|
Adverse events were monitored from signing of the informed consent form until follow-up for up to 30 days (±5 days) after the final day of IMP administration (end of trial date [final day of observation])
Subjects who received at least one dose of IMP were included in the safety analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | New Subjects | Newly entering elderly patients with major depressive disorder, aged 65 and over. 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal perforation | Gastrointestinal disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 23, 2020 | Jan 17, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2022 | Jan 17, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
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| Baseline and Week 52(LOCF) |
| The Proportion of Subjects Who Score 1 or 2 on the Clinical Global Impression-Improvement(CGI-I) Scale at Week 52(LOCF) | The CGI-I Scale was clinician-rated scale which assessed the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. | Baseline and Week 52 (LOCF) |
| Mean Changes From Baseline in Clinical Global Impression-Severity of Illness(CGI-S) at Week 52(LOCF) | The CGI-S Scale was a clinician-rated scale which assessed how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition. | Baseline and Week 52 (LOCF) |
| Mean Changes From Baseline in Hamiliton Depression Rating Scale(HAM-D) Item Total Scores at Week 52(LOCF) | The HAM-D was a clinician-rated scale which evaluated the level of depression. The HAM-D consists of 17 items such as depression mood, feeling of guilt, suicide, insomnia, work and activities, retardation, and so on. Each item was scored from 0 to 2, 3 or 4, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 53 , with higher score indicating worse condition. | Baseline and Week 52 (LOCF) |
| Mean Changes From Baseline in Sheehan Disability Scale (SDS) Scores at Week 52(LOCF) | SDS Scale was a patient-rated scale which assessed the degree of impairment for each of 3 items ("work/school," "social life," and "family life/home responsibilities") on a 11-point scale ranging from 0 to 10. The mean SDS score was the mean of scores for 3 items. Higher scores indicate worse condition. | Baseline and Week 52 (LOCF) |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Non-compliance With Study Drug |
|
| Physician Decision |
|
Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Mean Changes From Baseline in Montgomery Ã…sberg Depression Rating Scale(MADRS) Total Scores at Week 52(LOCF) | The MADRS was a clinician-rated scale which evaluated the level of depression.The MADRS consists of 10 items assessed apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item was scored from 0 to 6, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 60, with higher scores indicating worse condition. | The efficacy analysis set comprised subjects who have received at least 1 dose of the IMP, and from whom MADRS total scores have been obtained at baseline and at least 1 time point after initiation of the treatment. | Posted | Mean | Standard Error | Units on a scale | Baseline and Week 52(LOCF) |
|
|
|
| Secondary | The Proportion of Subjects Who Score 1 or 2 on the Clinical Global Impression-Improvement(CGI-I) Scale at Week 52(LOCF) | The CGI-I Scale was clinician-rated scale which assessed the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. | The efficacy analysis set comprised subjects who have received at least 1 dose of theIMP, and from whom MADRS total scores have been obtained at baseline and at least 1 time point after initiation of the treatment. | Posted | Number | percentage of Participants | Baseline and Week 52 (LOCF) |
|
|
|
| Secondary | Mean Changes From Baseline in Clinical Global Impression-Severity of Illness(CGI-S) at Week 52(LOCF) | The CGI-S Scale was a clinician-rated scale which assessed how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition. | The efficacy analysis set comprised subjects who have received at least 1 dose of theIMP, and from whom MADRS total scores have been obtained at baseline and at least 1 time point after initiation of the treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 52 (LOCF) |
|
|
|
| Secondary | Mean Changes From Baseline in Hamiliton Depression Rating Scale(HAM-D) Item Total Scores at Week 52(LOCF) | The HAM-D was a clinician-rated scale which evaluated the level of depression. The HAM-D consists of 17 items such as depression mood, feeling of guilt, suicide, insomnia, work and activities, retardation, and so on. Each item was scored from 0 to 2, 3 or 4, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 53 , with higher score indicating worse condition. | The efficacy analysis set comprised subjects who have received at least 1 dose of theIMP, and from whom MADRS total scores have been obtained at baseline and at least 1 time point after initiation of the treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 52 (LOCF) |
|
|
|
| Secondary | Mean Changes From Baseline in Sheehan Disability Scale (SDS) Scores at Week 52(LOCF) | SDS Scale was a patient-rated scale which assessed the degree of impairment for each of 3 items ("work/school," "social life," and "family life/home responsibilities") on a 11-point scale ranging from 0 to 10. The mean SDS score was the mean of scores for 3 items. Higher scores indicate worse condition. | The efficacy analysis set comprised subjects who have received at least 1 dose of theIMP, and from whom MADRS total scores have been obtained at baseline and at least 1 time point after initiation of the treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 52 (LOCF) |
|
|
|
| 0 |
| 31 |
| 1 |
| 31 |
| 30 |
| 31 |
| EG001 | Rollover Subjects | Participants who rolled over from, and received blinded brexpiprazole or placebo in the randomized, double-blind, placebo-controlled Phase 2/3 efficacy studies (331-102-00058); 2 mg/day (starting dose 1mg/day) of Brexpiprazole were orally administered once daily | 1 | 216 | 8 | 216 | 201 | 216 |
| Death | General disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| HIV infection | Infections and infestations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Hyperprolactinaemia | Endocrine disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Primary hypogonadism | Endocrine disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Adenoviral conjunctivitis | Infections and infestations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Infected dermal cyst | Infections and infestations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Blood insulin increased | Investigations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Blood prolactin increased | Investigations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Electrocardiogram T wave inversion | Investigations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Bradykinesia | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Terminal insomnia | Psychiatric disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA ver. 24.0 | Non-systematic Assessment |
|
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