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To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects
Randomized, double-blind, placebo-controlled, multiple ascending dose, parallel-group, pharmacokinetic (PK) and pharmacodynamic (PD) study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caucasian 5 mg OPC | Experimental | OPC, opicapone, BIA 9-1067 |
|
| Caucasian 25 mg OPC | Experimental | OPC, opicapone, BIA 9-1067 |
|
| Caucasian 50 mg OPC | Experimental | OPC, opicapone, BIA 9-1067 |
|
| Caucasian Placebo | Placebo Comparator | Placebo, PLC |
|
| Japanese 5 mg OPC | Experimental | OPC, opicapone, BIA 9-1067 |
|
| Japanese 25 mg OPC | Experimental | OPC, opicapone, BIA 9-1067 |
|
| Japanese 50 mg OPC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIA 9-1067 | Drug | 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose. | Day 1 |
| Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | Cmax - maximum observed plasma concentration following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose | Day 10 |
| AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1) | AUC0-t - area under the concentration-time curve (AUC) from time zero to last time point with concentrations above the lower limit of quantitation of BIA 9-1067 following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose. | Day 1 |
| AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10) | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose |
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Inclusion Criteria:
Men or nonlactating and nonpregnant women;
Caucasian or Japanese subjects. Caucasian subjects are subjects of European descent; Japanese subjects must be first or second generation. Generations will be defined as follows:
Aged 18 to 65 years;
Body weight ≥50 kg;
Within BMI range 18.5 to 30 kg/m2, inclusive;
Healthy, as determined by the Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG. Creatinine and ALT levels must be strictly within the normal range for eligibility at Check-in;
Women of nonchildbearing potential must be surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or postmenopausal for ≥1 year;
Women of childbearing potential must be using an effective nonhormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he is the sole partner of that subject) for a period of at least 1 month before and after dose administration. Women of childbearing potential must have a negative pregnancy test result within 48 hours before the start of the first investigational medicinal product (IMP) administration. Hormonal contraceptives will not be allowed because the effect of BIA 9 1067 on the metabolism of hormonal contraceptives and vice versa is not yet known;
Nonsmokers, defined as having smoked ≤10 cigarettes per week for the 3 months prior to dosing, abstained from smoking for 7 days prior to Check-in, and having a negative cotinine level ≤500 ng/mL at Check-in;
Have a high probability for compliance with and completion of the study, in the opinion of the Investigator;
Able to comprehend and willing to sign an ICF.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haejung Marr, MD | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc. | Honolulu | Hawaii | 96813 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Caucasian 5 mg OPC | OPC, opicapone, BIA 9-1067 (once-daily). |
| FG001 | Caucasian 25 mg OPC | OPC, opicapone, BIA 9-1067 (once-daily). |
| FG002 | Caucasian 50 mg OPC | OPC, opicapone, BIA 9-1067 (once-daily). |
| FG003 | Caucasian Placebo | Placebo, PLC Placebo: once-daily |
| FG004 | Japanese 5 mg OPC | OPC, opicapone, BIA 9-1067 (once-daily). |
| FG005 | Japanese 25 mg OPC | OPC, opicapone, BIA 9-1067 (once-daily). |
| FG006 | Japanese 50 mg OPC | OPC, opicapone, BIA 9-1067 (once-daily). |
| FG007 | Japanese Placebo | Placebo, PLC Placebo: once-daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caucasian 5 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
| BG001 | Caucasian 25 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose. | Posted | Mean | Standard Deviation | ng/mL | Day 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caucasian 5 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vessel puncture site haematoma | General disorders | MedDRA (14.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Research | Bial - Portela & Cª, S.A. | +351 229 866 100 | jose.rocha@bial.com |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C549349 | opicapone |
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| Experimental |
OPC, opicapone, BIA 9-1067 |
|
| Japanese Placebo | Placebo Comparator | Placebo, PLC |
|
| Placebo | Drug | once-daily |
|
| Day 10 |
| AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1) | AUC0-∞ - area under the concentration of BIA 9-1067-time curve (AUC) from time zero to infinity following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose | Day 1 |
| AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10) | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose | Day 10 |
| Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | Tmax of BIA 9-1067 - time taken to reach maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose | Day 1 |
| Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose | Day 10 |
| BG002 | Caucasian 50 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
| BG003 | Caucasian Placebo | Placebo, PLC Placebo: once-daily |
| BG004 | Japanese 5 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
| BG005 | Japanese 25 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
| BG006 | Japanese 50 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
| BG007 | Japanese Placebo | Placebo, PLC Placebo: once-daily |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Caucasian 50 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
| OG003 | Japanese 5 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
| OG004 | Japanese 25 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
| OG005 | Japanese 50 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). |
|
|
| Primary | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | Cmax - maximum observed plasma concentration following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose | Posted | Mean | Standard Deviation | ng/mL | Day 10 |
|
|
|
| Primary | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1) | AUC0-t - area under the concentration-time curve (AUC) from time zero to last time point with concentrations above the lower limit of quantitation of BIA 9-1067 following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose. | Posted | Mean | Standard Deviation | ng.h/mL | Day 1 |
|
|
|
| Primary | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10) | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose | Posted | Mean | Standard Deviation | ng.h/mL | Day 10 |
|
|
|
| Primary | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1) | AUC0-∞ - area under the concentration of BIA 9-1067-time curve (AUC) from time zero to infinity following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose | Posted | Mean | Standard Deviation | ng.h/mL | Day 1 |
|
|
|
| Primary | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10) | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose | Posted | Mean | Standard Deviation | ng.h/mL | Day 10 |
|
|
|
| Primary | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | Tmax of BIA 9-1067 - time taken to reach maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose | Posted | Median | Full Range | hours | Day 1 |
|
|
|
| Primary | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose | Posted | Median | Full Range | hours | Day 10 |
|
|
|
| 0 |
| 13 |
| 7 |
| 13 |
| EG001 | Caucasian 25 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). | 0 | 12 | 5 | 12 |
| EG002 | Caucasian 50 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). | 0 | 11 | 6 | 11 |
| EG003 | Caucasian Placebo | Placebo, PLC Placebo: once-daily | 0 | 15 | 8 | 15 |
| EG004 | Japanese 5 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). | 0 | 14 | 3 | 14 |
| EG005 | Japanese 25 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). | 0 | 14 | 6 | 14 |
| EG006 | Japanese 50 mg OPC | OPC, opicapone, BIA 9-1067 BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). | 0 | 12 | 6 | 12 |
| EG007 | Japanese Placebo | Placebo, PLC Placebo: once-daily | 0 | 14 | 5 | 14 |
| Vessel puncture site pain | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Irritability | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Musculoskeletal stifness | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Eyelid irritation | Eye disorders | MedDRA (14.0) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (14.0) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
| Energy increased | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA (14.0) | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Laceratioin | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (14.0) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (14.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
|
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |