| Primary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in participants or clinical investigation participant which did not necessarily have to have been related to the investigational medical product (IMP). AEs were recorded from time of informed consent through the follow-up visit at 2 weeks (±2 days) after IMP administration. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Count of Participants | | Participants | | Baseline up to 2 weeks after IMP administration (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Tolerability Questionnaire Score at Approximately 15 Minutes, 1, 4, 24, 48 Hours After DaTSCAN™ Ioflupane (123I) Injection as Measured by VAS (Visual Analogue Scale) | Tolerability questionnaire evaluated participants mood, pain at injection site, itchiness of injection site, loss of function at injection site and quality of sleep using 100 millimeter (mm) VAS. VAS is a continuous scale comprised of a horizontal line, usually 100 mm in length, where "0" stands for bad, and 100 mm stands for good. Higher score indicated better health outcomes. | The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints and "0" in the number analyzed field denotes that none of the participants were assessed at the specified timepoint. | Posted | | Mean | Standard Deviation | millimeter (mm) | | 1 hour before injection (baseline), and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints | Physical examination included recording an assessment for the presence of abnormalities of the following: general appearance, skin, lungs, cardiovascular system, back and spine, abdomen, extremities, lymph nodes, and neurological exam. Clinical significance was determined by investigator. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Count of Participants | | Participants | | Baseline, 4 hours after injection and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Hematology Parameters at Pre-specified Timepoints | Change from baseline in activated partial thromboplastin time, prothrombin time, thrombin time were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | seconds | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints | Change from baseline in C reactive protein were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | milligrams per liter (mg/L) | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints | Change from baseline in hematocrit were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | percent of red blood cells | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints | Change from baseline in erythrocytes were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints | Change from baseline in leukocytes, platelets timepoints were reported. | The safety population included all participants who received ioflupane (123I). | Posted | | Mean | Standard Deviation | 10^9 cells per liter | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints | Change from baseline in fibrinogen, hemoglobin were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | grams per liter (g/L) | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints | Change from baseline in albumin, protein were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | gram per liter (g/L) | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints | Change from baseline in thyroxine, free and triiodothyronine, free were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | picomoles per liter (pmol/L) | | Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints | Change from baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | international units per Liter (IU/L) | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints | Change from baseline in thyroxine and triiodothyronine were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | nanomoles per litre (nmol/L) | | Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints | Change from baseline in bilirubin, creatinine, direct bilirubin, and urate were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | micromole per litre (umol/L) | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints | Change from baseline in bicarbonate, calcium, chloride, glucose, phosphate, potassium, sodium, urea nitrogen were reported. | The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints. | Posted | | Mean | Standard Deviation | millimoles per liter (mmol/L) | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints | Change from baseline in thyrotropin were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | milli-international units per liter | | Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints | Change from baseline in amylase were reported. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Mean | Standard Deviation | units per liter (U/L) | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints | Number of participants with clinically significant abnormal pH and specific gravity were reported. Clinical significance was determined by investigator. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Count of Participants | | Participants | | Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints | Any radiopharmaceutical extravasation, bleeding, hematoma, redness, infection, or other findings were considered as abnormal findings. | The safety population included all participants who received ioflupane (123I) injection. | Posted | | Count of Participants | | Participants | | Baseline, up to 4 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints | Change from baseline in systolic blood pressure were reported. | The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | millimeters of mercury (mmHg) | | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints | Change from baseline in diastolic blood pressure were reported. | The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | mmHg | | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints | Change from baseline in heart rate were reported. | The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | beats/min | | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints | Change from baseline in temperature were reported. | The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | degrees celsius (°C) | | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints | Change from baseline in respiratory rate were reported. | The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints. | Posted | | Mean | Standard Deviation | breaths/min | | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Oxygen Saturation at Pre-specified Timepoints | Change from baseline in oxygen saturation were reported. | The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | percent oxygen (%) | | Baseline, 10, 20, 30 minutes and 1, 2, 4, 24, 48 hours and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days) | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Primary | Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints | Change from baseline in PR interval, QRS interval, QT interval, QTC interval, RR interval, QTCF interval, QTCB interval were reported. | The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints. | Posted | | Mean | Standard Deviation | milliseconds (msec) | | Baseline, 2 and 5 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Secondary | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood) | The decay-corrected %IA was measured by planar scintigraphy. The biodistribution as measured by the decay-corrected %IA in the plasma and whole blood at specified timepoints were reported. | Pharmacokinetic (PK) population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had greater than or equal to (>=) 1 set of images and >=1 blood sampling at prespecified time points. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints. | Posted | | Mean | Standard Deviation | %IA | | Pre-dose, 5, 15, 30 minutes and 1, 2, 3, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Secondary | Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image | The decay-corrected %IA was measured by planar scintigraphy. The biodistribution as measured by the decay-corrected %IA in the whole-body image which included background, heart, intestines, liver, lungs, salivary glands, stomach, striatum, thyroid, whole body, whole brain) at specified timepoints were reported. | PK population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had >=1 set of images and >=1 blood sampling at prespecified time points. Here, number analyzed signifies participants who were evaluable for given categories at specified timepoints. | Posted | | Mean | Standard Deviation | %IA | | 10 minutes and 1, 2, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Secondary | Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity | Biodistribution measured by decay corrected normalized cumulative activity in bladder content, brain, gallbladder, liver, lower large intestine, lungs, remainder, small intestine, upper large intestine was reported. | PK population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had >=1 set of images and >=1 blood sampling at prespecified time points. | Posted | | Mean | Standard Deviation | becquerel·hour/ becquerel (MBq·h / MBq) | | Up to 48 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Secondary | Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine | Excretion of 123I following the IV administration of ioflupane (123I) Injection was determined by measuring the 123I activity within the intestinal contents and the sum of the 123I activities in the voided urine up to 48 hours post-injection. | PK population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had >=1 set of images and >=1 blood sampling at prespecified time points. | Posted | | Mean | Standard Deviation | %IA (per hour) | | 10 minutes and 1, 2, 3, 4, 5, 5 to 24, and 24 to 48 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Secondary | Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry | Sex-averaged normalized organ absorbed doses calculated according to Medical Internal Radiation Dose (MIRD) method. | PK population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had >=1 set of images and >=1 blood sampling at prespecified time points. "Testes" in category were assessed for male participants only. Here, number analyzed signifies participants who were evaluable for given categories. | Posted | | Mean | Standard Deviation | milligray/becquerel (mGy/MBq) | | Up to 48 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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| Secondary | Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration | The ED per unit of administered activity was evaluated from the ensemble of absorbed dose data. | PK population included all participants who received ioflupane (123I) injection, underwent planar scintigraphy, and had >=1 set of images and >=1 blood sampling at prespecified time points. | Posted | | Mean | Standard Deviation | millisievert/becquerel (mSv/MBq) | | Up to 48 hours after DaTSCAN™ ioflupane (123I) injection | | | | ID | Title | Description |
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| OG000 | DaTSCAN™ Ioflupane (123I) Injection | Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV at Day 1; followed by planar whole-body imaging at 10 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 24 hours, and 48 hours after administration. Brain SPECT imaging was performed at 3 and 6 hours after administration. |
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