Trial Outcomes & Findings for Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia (NCT NCT01614912)
NCT ID: NCT01614912
Last Updated: 2022-04-12
Results Overview
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 three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social 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. 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
284 participants
Primary outcome timeframe
DB baseline and up to 32 weeks (LOCF endpoint)
Results posted on
2022-04-12
Participant Flow
Participant milestones
| Measure |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
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|---|---|
|
Overall Study
STARTED
|
284
|
|
Overall Study
COMPLETED
|
159
|
|
Overall Study
NOT COMPLETED
|
125
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
n=281 Participants
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
|
|---|---|
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Age, Continuous
|
43.2 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
126 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
76 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: DB baseline and up to 32 weeks (LOCF endpoint)Population: ITT (intent-to-treat) 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 three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social 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. 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 |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
n=281 Participants
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
|
|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at LOCF Endpoint
|
-28.4 units on a scale
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: DB baseline and up to 32 weeks (LOCF endpoint)Population: ITT (intent-to-treat) population
CGI-S is a clinician-rated assessment of the participant's current disease state on a 7-point scale, where a higher score is associated with greater severity of the disease. Baseline in the prior study (D1001056, double-blind \[DB\] baseline) was defined as baseline of the prior study. Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study. The last post-baseline visit data collected during the study treatment of the present study were carried forward and defined as the last observation carried forward (LOCF) endpoint.
Outcome measures
| Measure |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
n=281 Participants
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
|
|---|---|
|
Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at LOCF Endpoint
|
-1.46 units on a scale
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: DB baseline and up to 32 weeks (LOCF endpoint)Population: ITT (intent-to-treat) population
The PANSS is comprised of 30 items and three subscales. The Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. 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. The PANSS Positive subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.
Outcome measures
| Measure |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
n=281 Participants
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
|
|---|---|
|
Change From Baseline in PANSS Positive Subscale Score at LOCF Endpoint
|
-8.4 units on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: DB baseline and up to 32 weeks (LOCF endpoint)Population: ITT (intent-to-treat) population
The PANSS is comprised of 30 items and three subscales. The Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms. 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. The PANSS Negative subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.
Outcome measures
| Measure |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
n=281 Participants
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
|
|---|---|
|
Change From Baseline in PANSS Negative Subscale Score at LOCF Endpoint
|
-6.9 units on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: DB baseline and up to 32 weeks (LOCF endpoint)Population: ITT (intent-to-treat) population
The PANSS is comprised of 30 items and three subscales. The General Psychopathology subscale addresses other 16 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. The PANSS General Psychopathology subscale score is the sum of all 16 items and ranges from 16 through 112. A higher score is associated with greater illness severity.
Outcome measures
| Measure |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
n=281 Participants
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
|
|---|---|
|
Change From Baseline in PANSS General Psychopathology Subscale Score at LOCF Endpoint
|
-13.1 units on a scale
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: EXT baseline and up to 26 weeksPopulation: Safety population defined as subjects who receive at least one dose of the study drug.
Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a patient treated with a medicinal (investigational) product and which did not necessarily have a causal relationship with this treatment. Treatment-emergent adverse events are defined as adverse events with a start date on or after the date of initial administration of study drug in the present study through the end of follow-up or adverse events occurring before the date of initial administration of study drug in the present study and worsening during the study treatment in the present study.
Outcome measures
| Measure |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
n=282 Participants
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
|
|---|---|
|
Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs)
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215 Participants
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SECONDARY outcome
Timeframe: EXT baseline and up to 26 weeksPopulation: Safety population defined as subjects who receive at least one dose of the study drug.
Outcome measures
| Measure |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
n=282 Participants
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
|
|---|---|
|
Proportion of Participants With TEAEs Leading to Discontinuation
|
39 Participants
|
SECONDARY outcome
Timeframe: EXT baseline and up to 26 weeksPopulation: Safety population defined as subjects who receive at least one dose of the study drug.
Proportion of participants with treatment-emergent adverse events. A serious adverse event was defined as an AE that met one or more of the following criteria: Resulted in death; Was life-threatening (i.e., a patient was at immediate risk of death at the time of the event, not an event where occurrence in a more severe form might have caused death); Required hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability or incapacity; Was a congenital anomaly or birth defect; Was an important medical event that might jeopardize the patient or might require medical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
n=282 Participants
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
|
|---|---|
|
Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)
|
31 Participants
|
Adverse Events
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
Serious events: 31 serious events
Other events: 184 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
n=282 participants at risk
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Endocrine disorders
Diabetes insipidus
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Blood hyposmosis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Convulsion
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Psychotic disorder
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Restlessness
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Schizophrenia
|
6.0%
17/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Renal and urinary disorders
Renal failure acute
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
Other adverse events
| Measure |
SM-13496 (Lurasidone HCl) 40-mg or 80-mg Group
n=282 participants at risk
SM-13496 40 mg or 80 mg was orally administered for 26 weeks to the participants who completed the prior study (D1001056), in which, SM-13496 (40 mg or 80 mg) or placebo was administered for 6 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Cardiac disorders
Bradycardia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Cardiac disorders
Bundle branch block right
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Cardiac disorders
Long QT syndrome
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Cardiac disorders
Sinus bradycardia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Eye disorders
Vision blurred
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Eye disorders
Conjunctivitis
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Eye disorders
Chalazion
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Eye disorders
Conjunctivitis allergic
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Eye disorders
Diabetic retinopathy
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Eye disorders
Eye discharge
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Eye disorders
Eye pain
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Eye disorders
Posterior capsule opacification
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
16/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Constipation
|
3.5%
10/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
8/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
6/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
5/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
1.8%
5/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Stomatitis
|
1.8%
5/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
4/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Toothache
|
1.4%
4/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Periodontitis
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Dental caries
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Dry mouth
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
General disorders
Chest pain
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
General disorders
Oedema peripheral
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
General disorders
Chest discomfort
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
General disorders
Gait disturbance
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
General disorders
Pyrexia
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
General disorders
Drug ineffective
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
General disorders
Fatigue
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
General disorders
Irritability
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
General disorders
Malaise
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Immune system disorders
Hypersensitivity
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
30/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
14/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Influenza
|
1.8%
5/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Hordeolum
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Tinea pedis
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Cellulitis
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Acarodermatitis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Bronchitis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Bronchopneumonia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Carbuncle
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Dermatophytosis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Folliculitis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Furuncle
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Gastroenteritis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Genital infection fungal
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Impetigo
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Paronychia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Pharyngitis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Pulpitis dental
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Pyoderma
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Rhinitis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Sweating fever
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Tinea infection
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Tonsillitis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Urinary tract infection
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Infections and infestations
Vaginal infection
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.4%
4/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Blood prolactin increased
|
3.2%
9/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Weight increased
|
2.5%
7/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Blood uric acid increased
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Protein urine present
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Aspartate aminotransferase increased
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Blood cholesterol increased
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Blood creatinine increased
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Blood potassium increased
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Blood pressure decreased
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Hepatic enzyme increased
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Low density lipoprotein increased
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
Weight decreased
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Investigations
White blood cell count decreased
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Gout
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
9/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
6/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
6/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.4%
4/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
4/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Akathisia
|
11.0%
31/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Headache
|
5.3%
15/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Tremor
|
3.5%
10/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Dyskinesia
|
3.2%
9/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Dizziness
|
2.1%
6/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Dystonia
|
1.8%
5/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Bradykinesia
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Drooling
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Dysarthria
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Dyslalia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Hyperaesthesia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Hypoaesthesia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Migraine
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Oromandibular dystonia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Parkinsonian gait
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Parkinsonism
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Poor quality sleep
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Tardive dyskinesia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Insomnia
|
11.3%
32/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Schizophrenia
|
3.5%
10/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Anxiety
|
8.2%
23/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Psychotic disorder
|
1.4%
4/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Agitation
|
1.8%
5/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Aggression
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Depressed mood
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Abulia
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Impulsive behaviour
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Mental disorder
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Nervousness
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Persecutory delusion
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Psychiatric disorders
Suicidal ideation
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Renal and urinary disorders
Pollakiuria
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Renal and urinary disorders
Dysuria
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Renal and urinary disorders
Haematuria
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Renal and urinary disorders
Proteinuria
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Reproductive system and breast disorders
Balanitis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
5/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.1%
3/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.8%
8/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.5%
7/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
6/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
6/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Surgical and medical procedures
Tooth extraction
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Surgical and medical procedures
Dental care
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Vascular disorders
Hypertension
|
3.2%
9/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Vascular disorders
Hypotension
|
0.71%
2/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Vascular disorders
Haematoma
|
0.35%
1/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
|
Nervous system disorders
Somnolence
|
3.2%
9/282 • EXT baseline and up to 24 weeks
Baseline in the present study (D1001057, extension \[EXT\] baseline) was defined as Week 6 in the prior study (D1001056). Both TEAEs and treatment-emergent serious adverse events are presented for the safety population defined as subjects who receive at least one of the study drug. Patients experiencing multiple adverse events are counted once in each category.
|
Additional Information
Regional Function Head of CNS Research
Clinical Research, Drug Development Division
Phone: +81-3-5159-2519
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place