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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20191992 | Registry Identifier | China Drug Evalutation |
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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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This is a multicenter, open-label, non-controlled, non-randomized, phase 3 clinical study to compare the SPECT findings after a single IV administration of DaTSCAN™ ioflupane (123I) injection for patients with a clinical diagnosis of Parkinsonian syndrome (PS) involving striatal dopaminergic deficit (SDD; specifically, Parkinson's disease [PD] [SDD], multiple system atrophy [MSA] [SDD] or or progressive supranuclear palsy [PSP] [SDD]) as compared with patients with a clinical diagnosis of essential tremor (ET) (no SDD) and age-matched healthy controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DaTSCAN™ ioflupane (123I) injection | Experimental | Participants with Parkinsonian Syndrome (PS), Essential Tremor (ET), and Healthy Volunteers (HV) received a single dose of DaTSCAN™ ioflupane (123I) injection. Single photon emission computed tomography (SPECT) imaging was performed between 3 to 6 hours post-injection and lasted approximately 20 minutes to 1 hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane (123I) Injection | Drug | All participants (Participants with PS, ET, and HV) received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 megabecquerel (MBq) (3 to 5 millicurie [mCi]) per participant at a maximum volume of 5 milliliter [mL]) intravenously on Day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | Sensitivity was defined as positive percentage agreement and calculated as the number of true positives (TP) / (number of TP + number of false negatives [FN]): TP/(TP + FN), and a 2-sided 95% binomial confidence interval constructed around it. Only the participants with a clinical diagnosis of PS were included in the sensitivity analysis. The sensitivity of the blinded independent read of DaTSCAN™ SPECT images in detecting or excluding striatal dopaminergic deficit (SDD), when the clinical diagnosis as established by the investigator was used as the standard of truth, were summarized with by reader. Each participant's SPECT image was read by 3 blinded readers. | At Day 1 |
| Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | Specificity was defined as negative percentage agreement and calculated as the number of true negatives (TN) / (number of TN + number of false positives [FP]): TN/(TN + FP), and a 2-sided 95% binomial confidence interval constructed around it. For the specificity analysis, only participants with a clinical diagnosis of ET were included; the HVs were excluded from this analysis. The specificity of the blinded independent read of DaTSCAN™ SPECT images in detecting or excluding striatal dopaminergic deficit (SDD), when the clinical diagnosis as established by the investigator was used as the standard of truth, were summarized with by reader. Each participant's SPECT image was read by 3 blinded readers. | At Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | A semi-quantitative analysis of the striatal uptake ratios in specific regions of interest (ROIs, i.e., left and right striatum, caudate, and putamen) of DaTSCAN™ SPECT images was performed with DaTQUANT™. | At Day 1 |
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Inclusion Criteria:
For all participants:
Chinese male or female, aged 40 to 80 years, has agreed to sign and date the written informed consent form.
For Healthy Volunteers:
Non-patient volunteers with good age-appropriate health as established by clinical examination during screening and no evidence of movement disorder by complete neurological evaluation.
For participants with Parkinson's disease:
A diagnosis of clinically established or clinically probable PD in accordance with the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease.
For participants with MSA (SDD):
A diagnosis of probable or possible MSA in accordance with the Second Consensus Statement on the Diagnosis of MSA.
For participants with PSP (SDD):
A diagnosis of probable or possible PSP in accordance with the Clinical Criteria for the Diagnosis of Progressive Supranuclear Palsy National Institute for Neurological Disorders and Society for PSP (NINDS-SPSP)
For participants with ET (no SDD):
A diagnosis of definite or probable ET in accordance with the Washington Heights-Inwood Genetic Study of Essential Tremor (WHIGET) diagnostic criteria for ET (no SDD) .
Exclusion Criteria:
The participant is lactating.
The participant is pregnant as detected by a β-human chorionic gonadotropin (β-hCG) pregnancy test.
A cerebral structural vascular abnormality indicative of at least 1 infarction in the region of the basal ganglia (including the internal capsule) ≥5 mm has been confirmed, preferably by magnetic resonance imaging (MRI) performed within 6 months of screening. If an MRI is not clinically feasible, cerebral CT imaging within 6 months is also acceptable.
The participant is diagnosed with major neurocognitive disorder by the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria, or Mini-Mental State Examination total score is <24.
Participant is being investigated for or has been diagnosed and/or is being treated for repeated stroke with stepwise progression of Parkinson features.
History of repeated head injury (≥3 concussions, or history of professional sports with repeated head trauma [e.g., boxing]).
History of definite encephalitis (≥1 episode of confirmed encephalitis with objective residual neurologic deficit).
The participant is using or has insufficient washout from medication known or suspected to interact with striatal uptake through direct competition with binding of DaTSCAN™ to the dopamine transporters (i.e., amphetamine, benztropine, bupropion, cocaine, mazindol, methylphenidate, phentermine, sertraline, selective serotonin reuptake inhibitors) before the imaging visit.
The participant is using Chinese traditional medicine for PD treatment, which cannot be safely withdrawn for at least 1 week (7 days) before the imaging visit.
The participant has a moderate to severe renal impairment (e.g., serum creatinine >1.5x upper limit of normal [ULN], blood urea nitrogen [BUN] >30 mg/dL).
The participant has a moderate to severe hepatic impairment (bilirubin >2x ULN and alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>3x ULN).
The participant has a history of current abuse of drugs and/or alcohol (for the previous 12 months before trial enrolment).
The participant has a history of occupational exposure to any radiation >50 millisievert/year (mSv/year).
The participant has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or any radiopharmaceutical within a minimum of 5 radioactive half-lives prior to screening.
The participant presents with symptoms suggestive of corticobasal degeneration or Huntington's disease.
The participant has known allergies to the investigational medicinal product (IMP).
The participant presents with any clinically active, serious, life-threatening disease with a life expectancy of less than 12 months.
Any laboratory value(s) exceeding the limits of normality if deemed to be clinically relevant by the investigator.
The participant complains of claustrophobia.
The participant has a moderate to severe thyroid disease (thyroid stimulating hormone [TSH] exceeding the limits of normality by more than 10%), if deemed to be clinically relevant by the investigator.
For participants with ET:
The participant has at least 1 first-degree relative diagnosed with PD.
For Healthy Volunteers:
History of psychiatric illness.
For all participants:
It is the physician's best judgment not to include the participant in the trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Chaoyang District | 100029 | China | ||
| Peking Union Medical College Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 megabecquerel (MBq) (3 to 5 millicurie [mCi]) per participant at a maximum volume of 5 milliliter [mL] intravenously on Day 1. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 25, 2020 | Dec 13, 2022 |
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|
|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this investigational product (IP) or medicinal product. A Serious Adverse Event(SAE) was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of participants with TEAEs and serious TEAEs were reported. | From start of study drug administration up to Day 4 |
| Beijing |
| Dongcheng District |
| 100730 |
| China |
| Nanfang Hospital, Nanfang Medical Univeristy | Guangdong | Guangzhou | China |
| Nanjing First Hospital | Nanjing | Jiangsu | 2100029 | China |
| The Second Affilicated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
| Shanghai General Hospital | Hongkou | Shanghai Municipality | 200080 | China |
| Peking University First Hospital | Beijing | 100034 | China |
| Beijing Friendship Hospital Afflication to Capital Medical University | Beijing | 100050 | China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | 200025 | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) |
Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. |
| FG002 | DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all participants who received an injection of Investigational Medicinal Product (IMP).
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| ID | Title | Description |
|---|---|---|
| BG000 | DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. |
| BG001 | DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. |
| BG002 | DaTSCAN™ Ioflupane: Healthy Volunteer (HV) | Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | Sensitivity was defined as positive percentage agreement and calculated as the number of true positives (TP) / (number of TP + number of false negatives [FN]): TP/(TP + FN), and a 2-sided 95% binomial confidence interval constructed around it. Only the participants with a clinical diagnosis of PS were included in the sensitivity analysis. The sensitivity of the blinded independent read of DaTSCAN™ SPECT images in detecting or excluding striatal dopaminergic deficit (SDD), when the clinical diagnosis as established by the investigator was used as the standard of truth, were summarized with by reader. Each participant's SPECT image was read by 3 blinded readers. | Full-analysis set (FAS) consisted of all participants who had both a DaTSCAN™ image set and a clinical diagnosis made by the Investigator. Only the participants with a clinical diagnosis of PS were included in the sensitivity analysis. | Posted | Number | 95% Confidence Interval | ratio | At Day 1 |
|
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| Secondary | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | A semi-quantitative analysis of the striatal uptake ratios in specific regions of interest (ROIs, i.e., left and right striatum, caudate, and putamen) of DaTSCAN™ SPECT images was performed with DaTQUANT™. | Full-analysis set (FAS) consisted of all participants who had both a DaTSCAN™ image set and a clinical diagnosis made by the Investigator. | Posted | Mean | Standard Deviation | ratio | At Day 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this investigational product (IP) or medicinal product. A Serious Adverse Event(SAE) was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of participants with TEAEs and serious TEAEs were reported. | Safety population included all participants who received an injection of Investigational Medicinal Product (IMP). | Posted | Count of Participants | Participants | From start of study drug administration up to Day 4 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | Specificity was defined as negative percentage agreement and calculated as the number of true negatives (TN) / (number of TN + number of false positives [FP]): TN/(TN + FP), and a 2-sided 95% binomial confidence interval constructed around it. For the specificity analysis, only participants with a clinical diagnosis of ET were included; the HVs were excluded from this analysis. The specificity of the blinded independent read of DaTSCAN™ SPECT images in detecting or excluding striatal dopaminergic deficit (SDD), when the clinical diagnosis as established by the investigator was used as the standard of truth, were summarized with by reader. Each participant's SPECT image was read by 3 blinded readers. | Full-analysis set (FAS) consisted of all participants who had both a DaTSCAN™ image set and a clinical diagnosis made by the Investigator. Only participants with a clinical diagnosis of ET were included and the HVs were excluded from the specificity analysis. | Posted | Number | 95% Confidence Interval | ratio | At Day 1 |
|
|
From start of study drug administration up to Day 4
Safety population included all participants who received an injection of IMP.
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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 | DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 milliliter [mL] intravenously on Day 1. | 0 | 75 | 0 | 75 | 12 | 75 |
| EG001 | DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. | 0 | 75 | 0 | 75 | 13 | 75 |
| EG002 | DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. | 0 | 22 | 0 | 22 | 8 | 22 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Injection site paraesthesia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Protein urine present | Investigations | MedDRA 24.1 | Systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Blood phosphorus decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Urinary occult blood positive | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yongqing Tang, MD, PhD | GE Healthcare Ltd. | 21 38774044 | +86 | Yongqing.Tang@ge.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2021 | Dec 13, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D010300 | Parkinson Disease |
| D019578 | Multiple System Atrophy |
| D013494 | Supranuclear Palsy, Progressive |
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D024801 | Tauopathies |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000614958 | Iodine-123 |
| D007267 | Injections |
| C519528 | ioflupane |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|
Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. |
| OG002 | DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. |
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| Participants |
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