Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-27 @ 9:10 PM
Study NCT ID:
NCT04564092
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2020-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614958', 'term': 'Iodine-123'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'C519528', 'term': 'ioflupane'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Yongqing.Tang@ge.com', 'phone': '189-1820-3986', 'title': 'Yongqing Tang, MD PhD', 'organization': 'GE Healthcare'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)', 'eventGroups': [{'id': 'EG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Thyroiditis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Red blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Urinary occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': '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)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Itchiness of Injection Site: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Itchiness of Injection Site: Change at 15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'Itchiness of Injection Site: Change at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'Itchiness of Injection Site: Change at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'Itchiness of Injection Site: Change at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Itchiness of Injection Site: Change at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Loss of Function at Injection Site: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Loss of Function at Injection Site: Change at 15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Loss of Function at Injection Site: Change at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Loss of Function at Injection Site: Change at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Loss of Function at Injection Site: Change at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Loss of Function at Injection Site: Change at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Pain at Injection Site: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Pain at Injection Site: Change at 15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '7.88', 'groupId': 'OG000'}]}]}, {'title': 'Pain at Injection Site: Change at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Pain at Injection Site: Change at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Pain at Injection Site: Change at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Pain at Injection Site: Change at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Quality of Sleep: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.4', 'spread': '14.55', 'groupId': 'OG000'}]}]}, {'title': 'Quality of Sleep: Change at 15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Quality of Sleep: Change at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Quality of Sleep: Change at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Quality of Sleep: Change at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '11.69', 'groupId': 'OG000'}]}]}, {'title': 'Quality of Sleep: Change at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '12.34', 'groupId': 'OG000'}]}]}, {'title': 'Volunteer Mood: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.0', 'spread': '11.38', 'groupId': 'OG000'}]}]}, {'title': 'Volunteer Mood: Change at 15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '6.31', 'groupId': 'OG000'}]}]}, {'title': 'Volunteer Mood: Change at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '11.82', 'groupId': 'OG000'}]}]}, {'title': 'Volunteer Mood: Change at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '7.69', 'groupId': 'OG000'}]}]}, {'title': 'Volunteer Mood: Change at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '9.73', 'groupId': 'OG000'}]}]}, {'title': 'Volunteer Mood: Change at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '10.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour before injection (baseline), and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': '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.', 'unitOfMeasure': 'millimeter (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'At Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'At 4 hours', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'At 2 weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 4 hours after injection and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology Parameters at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Activated Partial Thromboplastin Time: At Baseline', 'categories': [{'measurements': [{'value': '29.68', 'spread': '2.241', 'groupId': 'OG000'}]}]}, {'title': 'Activated Partial Thromboplastin Time: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '2.316', 'groupId': 'OG000'}]}]}, {'title': 'Activated Partial Thromboplastin Time: Change at 48 Hours', 'categories': [{'measurements': [{'value': '0.06', 'spread': '2.410', 'groupId': 'OG000'}]}]}, {'title': 'Activated Partial Thromboplastin Time: Change at 2 weeks', 'categories': [{'measurements': [{'value': '0.11', 'spread': '2.395', 'groupId': 'OG000'}]}]}, {'title': 'Prothrombin Time: At Baseline', 'categories': [{'measurements': [{'value': '11.75', 'spread': '0.472', 'groupId': 'OG000'}]}]}, {'title': 'Prothrombin Time: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.715', 'groupId': 'OG000'}]}]}, {'title': 'Prothrombin Time: Change at 48 Hours', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.370', 'groupId': 'OG000'}]}]}, {'title': 'Prothrombin Time: Change at 2 weeks', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.365', 'groupId': 'OG000'}]}]}, {'title': 'Thrombin Time: At Baseline', 'categories': [{'measurements': [{'value': '18.48', 'spread': '1.229', 'groupId': 'OG000'}]}]}, {'title': 'Thrombin Time: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '1.753', 'groupId': 'OG000'}]}]}, {'title': 'Thrombin Time: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '1.567', 'groupId': 'OG000'}]}]}, {'title': 'Thrombin Time: Change at 2 weeks', 'categories': [{'measurements': [{'value': '0.06', 'spread': '1.530', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in activated partial thromboplastin time, prothrombin time, thrombin time were reported.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'At Baseline', 'categories': [{'measurements': [{'value': '0.906', 'spread': '0.9608', 'groupId': 'OG000'}]}]}, {'title': 'Change at 3 Hours', 'categories': [{'measurements': [{'value': '-0.106', 'spread': '1.5956', 'groupId': 'OG000'}]}]}, {'title': 'Change at 48 Hours', 'categories': [{'measurements': [{'value': '-0.219', 'spread': '1.1784', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 weeks', 'categories': [{'measurements': [{'value': '-0.231', 'spread': '0.6181', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in C reactive protein were reported.', 'unitOfMeasure': 'milligrams per liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'At Baseline', 'categories': [{'measurements': [{'value': '0.4184', 'spread': '0.03175', 'groupId': 'OG000'}]}]}, {'title': 'Change at 3 Hours', 'categories': [{'measurements': [{'value': '-0.0128', 'spread': '0.01855', 'groupId': 'OG000'}]}]}, {'title': 'Change at 48 Hours', 'categories': [{'measurements': [{'value': '0.0075', 'spread': '0.02798', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 weeks', 'categories': [{'measurements': [{'value': '-0.0140', 'spread': '0.01595', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in hematocrit were reported.', 'unitOfMeasure': 'percent of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'At Baseline', 'categories': [{'measurements': [{'value': '4.711', 'spread': '0.5148', 'groupId': 'OG000'}]}]}, {'title': 'Change at 3 Hours', 'categories': [{'measurements': [{'value': '-0.098', 'spread': '0.1529', 'groupId': 'OG000'}]}]}, {'title': 'Change at 48 Hours', 'categories': [{'measurements': [{'value': '0.099', 'spread': '0.2898', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 weeks', 'categories': [{'measurements': [{'value': '-0.143', 'spread': '0.1648', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in erythrocytes were reported.', 'unitOfMeasure': '10^12 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Leukocytes: At Baseline', 'categories': [{'measurements': [{'value': '6.933', 'spread': '1.6311', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-0.280', 'spread': '2.2782', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-1.173', 'spread': '2.3201', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes: Change at 2 weeks', 'categories': [{'measurements': [{'value': '-0.384', 'spread': '2.5467', 'groupId': 'OG000'}]}]}, {'title': 'Platelets: At Baseline', 'categories': [{'measurements': [{'value': '255.8', 'spread': '43.82', 'groupId': 'OG000'}]}]}, {'title': 'Platelets: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-30.1', 'spread': '25.22', 'groupId': 'OG000'}]}]}, {'title': 'Platelets: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-14.4', 'spread': '30.40', 'groupId': 'OG000'}]}]}, {'title': 'Platelets: Change at 2 weeks', 'categories': [{'measurements': [{'value': '0.1', 'spread': '36.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in leukocytes, platelets timepoints were reported.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I).'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Fibrinogen: At Baseline', 'categories': [{'measurements': [{'value': '2.61', 'spread': '0.470', 'groupId': 'OG000'}]}]}, {'title': 'Fibrinogen: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.344', 'groupId': 'OG000'}]}]}, {'title': 'Fibrinogen: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.480', 'groupId': 'OG000'}]}]}, {'title': 'Fibrinogen: Change at 2 weeks', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.518', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin: At Baseline', 'categories': [{'measurements': [{'value': '141.3', 'spread': '13.41', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '6.27', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin: Change at 48 Hours', 'categories': [{'measurements': [{'value': '3.5', 'spread': '10.65', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin: Change at 2 weeks', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '4.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in fibrinogen, hemoglobin were reported.', 'unitOfMeasure': 'grams per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Albumin: Baseline', 'categories': [{'measurements': [{'value': '45.8', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Albumin: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.19', 'groupId': 'OG000'}]}]}, {'title': 'Albumin: Change at 48 Hours', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.76', 'groupId': 'OG000'}]}]}, {'title': 'Albumin: Change at 2 Weeks', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Protein: Baseline', 'categories': [{'measurements': [{'value': '73.3', 'spread': '4.03', 'groupId': 'OG000'}]}]}, {'title': 'Protein: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '3.60', 'groupId': 'OG000'}]}]}, {'title': 'Protein: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3.89', 'groupId': 'OG000'}]}]}, {'title': 'Protein: Change at 2 Weeks', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '3.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in albumin, protein were reported.', 'unitOfMeasure': 'gram per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Thyroxine, Free: Baseline', 'categories': [{'measurements': [{'value': '12.580', 'spread': '1.8109', 'groupId': 'OG000'}]}]}, {'title': 'Thyroxine, Free: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-0.208', 'spread': '0.6362', 'groupId': 'OG000'}]}]}, {'title': 'Triiodothyronine, Free: Baseline', 'categories': [{'measurements': [{'value': '4.400', 'spread': '0.3540', 'groupId': 'OG000'}]}]}, {'title': 'Triiodothyronine, Free: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-0.179', 'spread': '0.4639', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Change from baseline in thyroxine, free and triiodothyronine, free were reported.', 'unitOfMeasure': 'picomoles per liter (pmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Alanine aminotransferase; Baseline', 'categories': [{'measurements': [{'value': '17.6', 'spread': '4.72', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '4.26', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '5.29', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase: Change at 2 weeks', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '7.01', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase: Baseline', 'categories': [{'measurements': [{'value': '72.3', 'spread': '22.04', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '7.55', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase: Change at 48 Hours', 'categories': [{'measurements': [{'value': '2.8', 'spread': '5.85', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline phosphatase: Change at 2 weeks', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '5.40', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase: Baseline', 'categories': [{'measurements': [{'value': '20.8', 'spread': '3.41', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase: Change at 3 Hours', 'categories': [{'measurements': [{'value': '4.8', 'spread': '9.02', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase: Change at 48 Hours', 'categories': [{'measurements': [{'value': '0.5', 'spread': '5.83', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase: Change at 2 weeks', 'categories': [{'measurements': [{'value': '3.1', 'spread': '11.73', 'groupId': 'OG000'}]}]}, {'title': 'Creatine kinase: Baseline', 'categories': [{'measurements': [{'value': '128.5', 'spread': '102.11', 'groupId': 'OG000'}]}]}, {'title': 'Creatine kinase: Change at 3 Hours', 'categories': [{'measurements': [{'value': '11.4', 'spread': '38.95', 'groupId': 'OG000'}]}]}, {'title': 'Creatine kinase: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-46.5', 'spread': '67.83', 'groupId': 'OG000'}]}]}, {'title': 'Creatine kinase: Change at 2 weeks', 'categories': [{'measurements': [{'value': '599.6', 'spread': '1749.92', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase: Baseline', 'categories': [{'measurements': [{'value': '17.1', 'spread': '6.98', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.83', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.25', 'groupId': 'OG000'}]}]}, {'title': 'Gamma glutamyl transferase: Change at 2 weeks', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.75', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase: Baseline', 'categories': [{'measurements': [{'value': '173.0', 'spread': '45.69', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase: Change at 3 Hours', 'categories': [{'measurements': [{'value': '33.3', 'spread': '61.16', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase: Change at 48 Hours', 'categories': [{'measurements': [{'value': '12.1', 'spread': '46.10', 'groupId': 'OG000'}]}]}, {'title': 'Lactate dehydrogenase: Change at 2 weeks', 'categories': [{'measurements': [{'value': '39.1', 'spread': '72.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.', 'unitOfMeasure': 'international units per Liter (IU/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Thyroxine: Baseline', 'categories': [{'measurements': [{'value': '91.024', 'spread': '20.5161', 'groupId': 'OG000'}]}]}, {'title': 'Thyroxine: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-1.670', 'spread': '9.3900', 'groupId': 'OG000'}]}]}, {'title': 'Triiodothyronine: Baseline', 'categories': [{'measurements': [{'value': '1.458', 'spread': '0.2931', 'groupId': 'OG000'}]}]}, {'title': 'Triiodothyronine: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-0.035', 'spread': '0.2484', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Change from baseline in thyroxine and triiodothyronine were reported.', 'unitOfMeasure': 'nanomoles per litre (nmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Bilirubin: Baseline', 'categories': [{'measurements': [{'value': '15.21', 'spread': '6.316', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-1.54', 'spread': '6.135', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-1.70', 'spread': '5.478', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin: Change at 2 Weeks', 'categories': [{'measurements': [{'value': '-1.30', 'spread': '3.747', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine: Baseline', 'categories': [{'measurements': [{'value': '71.9', 'spread': '17.50', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-10.5', 'spread': '8.37', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '7.14', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine: Change at 2 Weeks', 'categories': [{'measurements': [{'value': '1.8', 'spread': '11.47', 'groupId': 'OG000'}]}]}, {'title': 'Direct Bilirubin: Baseline', 'categories': [{'measurements': [{'value': '2.69', 'spread': '0.958', 'groupId': 'OG000'}]}]}, {'title': 'Direct Bilirubin: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '1.056', 'groupId': 'OG000'}]}]}, {'title': 'Direct Bilirubin: Change at 48 Hours', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '1.053', 'groupId': 'OG000'}]}]}, {'title': 'Direct Bilirubin: Change at 2 Weeks', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.713', 'groupId': 'OG000'}]}]}, {'title': 'Urate: Baseline', 'categories': [{'measurements': [{'value': '305.1', 'spread': '64.21', 'groupId': 'OG000'}]}]}, {'title': 'Urate: Change at 3 Hours', 'categories': [{'measurements': [{'value': '-42.6', 'spread': '25.26', 'groupId': 'OG000'}]}]}, {'title': 'Urate: Change at 48 Hours', 'categories': [{'measurements': [{'value': '5.8', 'spread': '30.44', 'groupId': 'OG000'}]}]}, {'title': 'Urate: Change at 2 Weeks', 'categories': [{'measurements': [{'value': '14.5', 'spread': '34.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in bilirubin, creatinine, direct bilirubin, and urate were reported.', 'unitOfMeasure': 'micromole per litre (umol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Bicarbonate: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.31', 'spread': '1.912', 'groupId': 'OG000'}]}]}, {'title': 'Bicarbonate: Change at 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '3.036', 'groupId': 'OG000'}]}]}, {'title': 'Bicarbonate: Change at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.87', 'spread': '2.757', 'groupId': 'OG000'}]}]}, {'title': 'Bicarbonate: Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.40', 'spread': '2.198', 'groupId': 'OG000'}]}]}, {'title': 'Calcium: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.355', 'spread': '0.1207', 'groupId': 'OG000'}]}]}, {'title': 'Calcium: Change at 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.035', 'spread': '0.1214', 'groupId': 'OG000'}]}]}, {'title': 'Calcium: Change at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.1203', 'groupId': 'OG000'}]}]}, {'title': 'Calcium: Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.030', 'spread': '0.1390', 'groupId': 'OG000'}]}]}, {'title': 'Chloride: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '103.0', 'spread': '1.69', 'groupId': 'OG000'}]}]}, {'title': 'Chloride: Change at 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.20', 'groupId': 'OG000'}]}]}, {'title': 'Chloride: Change at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.51', 'groupId': 'OG000'}]}]}, {'title': 'Chloride: Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.25', 'groupId': 'OG000'}]}]}, {'title': 'Glucose: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.623', 'spread': '0.7060', 'groupId': 'OG000'}]}]}, {'title': 'Glucose: Change at 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.948', 'spread': '0.5832', 'groupId': 'OG000'}]}]}, {'title': 'Glucose: Change at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.073', 'spread': '0.6025', 'groupId': 'OG000'}]}]}, {'title': 'Glucose: Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.924', 'spread': '0.7686', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.089', 'spread': '0.2398', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate: Change at 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.2585', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate: Change at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.1745', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate: Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.2926', 'groupId': 'OG000'}]}]}, {'title': 'Potassium: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.051', 'spread': '0.2849', 'groupId': 'OG000'}]}]}, {'title': 'Potassium: Change at 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.151', 'spread': '0.4158', 'groupId': 'OG000'}]}]}, {'title': 'Potassium: Change at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.4538', 'groupId': 'OG000'}]}]}, {'title': 'Potassium: Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.108', 'spread': '0.2556', 'groupId': 'OG000'}]}]}, {'title': 'Sodium: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '139.6', 'spread': '2.20', 'groupId': 'OG000'}]}]}, {'title': 'Sodium: Change at 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.17', 'groupId': 'OG000'}]}]}, {'title': 'Sodium: Change at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.56', 'groupId': 'OG000'}]}]}, {'title': 'Sodium: Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.87', 'groupId': 'OG000'}]}]}, {'title': 'Urea Nitrogen: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.91', 'spread': '1.563', 'groupId': 'OG000'}]}]}, {'title': 'Urea Nitrogen: Change at 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '1.195', 'groupId': 'OG000'}]}]}, {'title': 'Urea Nitrogen: Change at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '1.421', 'groupId': 'OG000'}]}]}, {'title': 'Urea Nitrogen: Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '1.336', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in bicarbonate, calcium, chloride, glucose, phosphate, potassium, sodium, urea nitrogen were reported.', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Thyrotropin: Baseline', 'categories': [{'measurements': [{'value': '2.50395', 'spread': '2.052725', 'groupId': 'OG000'}]}]}, {'title': 'Thyrotropin: Change at 48 Hours', 'categories': [{'measurements': [{'value': '0.33034', 'spread': '0.879050', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Change from baseline in thyrotropin were reported.', 'unitOfMeasure': 'milli-international units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Amylase: Baseline', 'categories': [{'measurements': [{'value': '77.1', 'spread': '29.53', 'groupId': 'OG000'}]}]}, {'title': 'Amylase: Change at 3 Hours', 'categories': [{'measurements': [{'value': '18.9', 'spread': '48.01', 'groupId': 'OG000'}]}]}, {'title': 'Amylase: Change at 48 Hours', 'categories': [{'measurements': [{'value': '3.8', 'spread': '10.63', 'groupId': 'OG000'}]}]}, {'title': 'Amylase: Change at 2 Weeks', 'categories': [{'measurements': [{'value': '2.0', 'spread': '6.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in amylase were reported.', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'pH: At Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'pH: At 3 Hours', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'pH: At 48 Hours', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'pH: At 2 Weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Specific gravity: At Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Specific gravity: At 3 Hours', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Specific gravity: At 48 Hours', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Specific gravity: At 2 Weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Number of participants with clinically significant abnormal pH and specific gravity were reported. Clinical significance was determined by investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, up to 4 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Any radiopharmaceutical extravasation, bleeding, hematoma, redness, infection, or other findings were considered as abnormal findings.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '109.6', 'spread': '12.43', 'groupId': 'OG000'}]}]}, {'title': 'Change at 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '6.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at 20 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '5.69', 'groupId': 'OG000'}]}]}, {'title': 'Change at 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.8', 'spread': '4.80', 'groupId': 'OG000'}]}]}, {'title': 'Change at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '4.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '7.90', 'groupId': 'OG000'}]}]}, {'title': 'Change at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '7.65', 'groupId': 'OG000'}]}]}, {'title': 'Change at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '3.65', 'groupId': 'OG000'}]}]}, {'title': 'Change at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '4.63', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '8.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': 'Change from baseline in systolic blood pressure were reported.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.8', 'spread': '5.39', 'groupId': 'OG000'}]}]}, {'title': 'Change at 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '4.74', 'groupId': 'OG000'}]}]}, {'title': 'Change at 20 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '5.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '8.28', 'groupId': 'OG000'}]}]}, {'title': 'Change at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '7.98', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '9.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '7.38', 'groupId': 'OG000'}]}]}, {'title': 'Change at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '5.18', 'groupId': 'OG000'}]}]}, {'title': 'Change at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '5.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '6.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': 'Change from baseline in diastolic blood pressure were reported.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.4', 'spread': '12.84', 'groupId': 'OG000'}]}]}, {'title': 'Change at 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '10.49', 'groupId': 'OG000'}]}]}, {'title': 'Change at 20 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '7.40', 'groupId': 'OG000'}]}]}, {'title': 'Change at 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.6', 'spread': '9.90', 'groupId': 'OG000'}]}]}, {'title': 'Change at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': '9.61', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '5.61', 'groupId': 'OG000'}]}]}, {'title': 'Change at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '6.89', 'groupId': 'OG000'}]}]}, {'title': 'Change at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '8.25', 'groupId': 'OG000'}]}]}, {'title': 'Change at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '9.46', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '11.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': 'Change from baseline in heart rate were reported.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.45', 'spread': '0.239', 'groupId': 'OG000'}]}]}, {'title': 'Change at 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.350', 'groupId': 'OG000'}]}]}, {'title': 'Change at 20 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.519', 'groupId': 'OG000'}]}]}, {'title': 'Change at 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.301', 'groupId': 'OG000'}]}]}, {'title': 'Change at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.255', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.273', 'groupId': 'OG000'}]}]}, {'title': 'Change at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.377', 'groupId': 'OG000'}]}]}, {'title': 'Change at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.389', 'groupId': 'OG000'}]}]}, {'title': 'Change at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.316', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.290', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': 'Change from baseline in temperature were reported.', 'unitOfMeasure': 'degrees celsius (°C)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': 'Change at 20 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Change at 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.92', 'groupId': 'OG000'}]}]}, {'title': 'Change at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.64', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.39', 'groupId': 'OG000'}]}]}, {'title': 'Change at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': 'Change from baseline in respiratory rate were reported.', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Oxygen Saturation at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.0', 'spread': '1.93', 'groupId': 'OG000'}]}]}, {'title': 'Change at 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.31', 'groupId': 'OG000'}]}]}, {'title': 'Change at 20 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.16', 'groupId': 'OG000'}]}]}, {'title': 'Change at 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.05', 'groupId': 'OG000'}]}]}, {'title': 'Change at 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.81', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.47', 'groupId': 'OG000'}]}]}, {'title': 'Change at 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.33', 'groupId': 'OG000'}]}]}, {'title': 'Change at 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.01', 'groupId': 'OG000'}]}]}, {'title': 'Change at 2 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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)', 'description': 'Change from baseline in oxygen saturation were reported.', 'unitOfMeasure': 'percent oxygen (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection. Here, number analyzed signifies participants who were evaluable at specified timepoints.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'PR Interval: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '161.3', 'spread': '27.46', 'groupId': 'OG000'}]}]}, {'title': 'PR Interval: Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '10.36', 'groupId': 'OG000'}]}]}, {'title': 'PR Interval: Change at 5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '12.14', 'groupId': 'OG000'}]}]}, {'title': 'QRS Interval: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.0', 'spread': '10.09', 'groupId': 'OG000'}]}]}, {'title': 'QRS Interval: Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '5.32', 'groupId': 'OG000'}]}]}, {'title': 'QRS Interval: Change at 5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '3.55', 'groupId': 'OG000'}]}]}, {'title': 'QT Interval: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '406.0', 'spread': '25.94', 'groupId': 'OG000'}]}]}, {'title': 'QT Interval: Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '7.46', 'groupId': 'OG000'}]}]}, {'title': 'QT Interval: Change at 5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '14.58', 'groupId': 'OG000'}]}]}, {'title': 'QTC Interval: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '419.9', 'spread': '14.62', 'groupId': 'OG000'}]}]}, {'title': 'QTC Interval: Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '6.82', 'groupId': 'OG000'}]}]}, {'title': 'QTC Interval: Change at 5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '7.03', 'groupId': 'OG000'}]}]}, {'title': 'RR Interval: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '910.0', 'spread': '141.42', 'groupId': 'OG000'}]}]}, {'title': 'RR Interval: Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.0', 'spread': '60.24', 'groupId': 'OG000'}]}]}, {'title': 'RR Interval: Change at 5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '109.02', 'groupId': 'OG000'}]}]}, {'title': 'QTCF Interval: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '419.9', 'spread': '15.61', 'groupId': 'OG000'}]}]}, {'title': 'QTCF Interval: Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '9.40', 'groupId': 'OG000'}]}]}, {'title': 'QTCF Interval: Change at 5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '7.71', 'groupId': 'OG000'}]}]}, {'title': 'QTCB Interval: At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '427.6', 'spread': '20.32', 'groupId': 'OG000'}]}]}, {'title': 'QTCB Interval: Change at 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.3', 'spread': '13.35', 'groupId': 'OG000'}]}]}, {'title': 'QTCB Interval: Change at 5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '14.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 and 5 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Change from baseline in PR interval, QRS interval, QT interval, QTC interval, RR interval, QTCF interval, QTCB interval were reported.', 'unitOfMeasure': 'milliseconds (msec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Plasma: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.0074', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: 5 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.769', 'spread': '0.7735', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: 15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.686', 'spread': '0.5573', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.350', 'spread': '0.2935', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.351', 'spread': '0.2671', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.375', 'spread': '0.3407', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.338', 'spread': '0.3851', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.229', 'spread': '0.3360', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: 5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.138', 'spread': '0.3006', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.768', 'spread': '0.1817', 'groupId': 'OG000'}]}]}, {'title': 'Plasma: 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.626', 'spread': '0.1382', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.030', 'spread': '0.0093', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: 5 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.564', 'spread': '1.4710', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: 15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.798', 'spread': '0.9416', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.220', 'spread': '0.5049', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.220', 'spread': '0.4721', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.355', 'spread': '0.5505', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: 3 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.216', 'spread': '0.5506', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.081', 'spread': '0.4923', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: 5 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.924', 'spread': '0.4038', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.348', 'spread': '0.3392', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood: 48 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.098', 'spread': '0.3441', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 5, 15, 30 minutes and 1, 2, 3, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': '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.', 'unitOfMeasure': '%IA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Background: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.149', 'groupId': 'OG000'}]}]}, {'title': 'Background: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.181', 'groupId': 'OG000'}]}]}, {'title': 'Background: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.164', 'groupId': 'OG000'}]}]}, {'title': 'Background: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.151', 'groupId': 'OG000'}]}]}, {'title': 'Background: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.153', 'groupId': 'OG000'}]}]}, {'title': 'Background: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.120', 'groupId': 'OG000'}]}]}, {'title': 'Background: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.104', 'groupId': 'OG000'}]}]}, {'title': 'Heart: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.28', 'spread': '0.427', 'groupId': 'OG000'}]}]}, {'title': 'Heart: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.323', 'groupId': 'OG000'}]}]}, {'title': 'Heart: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.259', 'groupId': 'OG000'}]}]}, {'title': 'Heart: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.189', 'groupId': 'OG000'}]}]}, {'title': 'Heart: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.214', 'groupId': 'OG000'}]}]}, {'title': 'Heart: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.245', 'groupId': 'OG000'}]}]}, {'title': 'Heart: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.107', 'groupId': 'OG000'}]}]}, {'title': 'Intestines: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.30', 'spread': '2.821', 'groupId': 'OG000'}]}]}, {'title': 'Intestines: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.69', 'spread': '2.569', 'groupId': 'OG000'}]}]}, {'title': 'Intestines: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.95', 'spread': '3.254', 'groupId': 'OG000'}]}]}, {'title': 'Intestines: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.27', 'spread': '3.355', 'groupId': 'OG000'}]}]}, {'title': 'Intestines: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.91', 'spread': '3.550', 'groupId': 'OG000'}]}]}, {'title': 'Intestines: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.25', 'spread': '3.013', 'groupId': 'OG000'}]}]}, {'title': 'Intestines: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.29', 'spread': '2.523', 'groupId': 'OG000'}]}]}, {'title': 'Liver: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.14', 'spread': '2.392', 'groupId': 'OG000'}]}]}, {'title': 'Liver: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.31', 'spread': '3.419', 'groupId': 'OG000'}]}]}, {'title': 'Liver: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.08', 'spread': '3.066', 'groupId': 'OG000'}]}]}, {'title': 'Liver: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.84', 'spread': '0.914', 'groupId': 'OG000'}]}]}, {'title': 'Liver: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.21', 'spread': '0.975', 'groupId': 'OG000'}]}]}, {'title': 'Liver: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.80', 'spread': '1.611', 'groupId': 'OG000'}]}]}, {'title': 'Liver: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.13', 'spread': '0.772', 'groupId': 'OG000'}]}]}, {'title': 'Lungs: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.65', 'spread': '1.977', 'groupId': 'OG000'}]}]}, {'title': 'Lungs: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.80', 'spread': '1.788', 'groupId': 'OG000'}]}]}, {'title': 'Lungs: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.59', 'spread': '1.705', 'groupId': 'OG000'}]}]}, {'title': 'Lungs: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.61', 'spread': '1.152', 'groupId': 'OG000'}]}]}, {'title': 'Lungs: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.20', 'spread': '1.425', 'groupId': 'OG000'}]}]}, {'title': 'Lungs: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.36', 'spread': '1.682', 'groupId': 'OG000'}]}]}, {'title': 'Lungs: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.04', 'spread': '1.440', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Glands: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.053', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Glands: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.046', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Glands: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.053', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Glands: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.053', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Glands: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.053', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Glands: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.046', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Glands: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.035', 'groupId': 'OG000'}]}]}, {'title': 'Spleen: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.330', 'groupId': 'OG000'}]}]}, {'title': 'Spleen: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.239', 'groupId': 'OG000'}]}]}, {'title': 'Spleen: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.185', 'groupId': 'OG000'}]}]}, {'title': 'Spleen: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.168', 'groupId': 'OG000'}]}]}, {'title': 'Spleen: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.180', 'groupId': 'OG000'}]}]}, {'title': 'Spleen: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.074', 'groupId': 'OG000'}]}]}, {'title': 'Spleen: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.092', 'groupId': 'OG000'}]}]}, {'title': 'Stomach: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.74', 'spread': '0.684', 'groupId': 'OG000'}]}]}, {'title': 'Stomach: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.53', 'spread': '0.557', 'groupId': 'OG000'}]}]}, {'title': 'Stomach: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.450', 'groupId': 'OG000'}]}]}, {'title': 'Stomach: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.244', 'groupId': 'OG000'}]}]}, {'title': 'Stomach: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.204', 'groupId': 'OG000'}]}]}, {'title': 'Stomach: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.315', 'groupId': 'OG000'}]}]}, {'title': 'Stomach: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.130', 'groupId': 'OG000'}]}]}, {'title': 'Striatum: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.30', 'spread': '0.293', 'groupId': 'OG000'}]}]}, {'title': 'Striatum: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.249', 'groupId': 'OG000'}]}]}, {'title': 'Striatum: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.259', 'groupId': 'OG000'}]}]}, {'title': 'Striatum: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.216', 'groupId': 'OG000'}]}]}, {'title': 'Striatum: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.229', 'groupId': 'OG000'}]}]}, {'title': 'Striatum: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.167', 'groupId': 'OG000'}]}]}, {'title': 'Striatum: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.099', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.064', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.071', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.046', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.049', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.053', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.035', 'groupId': 'OG000'}]}]}, {'title': 'Whole body: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '104.09', 'spread': '13.451', 'groupId': 'OG000'}]}]}, {'title': 'Whole body: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '104.63', 'spread': '14.962', 'groupId': 'OG000'}]}]}, {'title': 'Whole body: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '103.41', 'spread': '12.974', 'groupId': 'OG000'}]}]}, {'title': 'Whole body: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.04', 'spread': '10.938', 'groupId': 'OG000'}]}]}, {'title': 'Whole body: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.53', 'spread': '10.859', 'groupId': 'OG000'}]}]}, {'title': 'Whole body: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.96', 'spread': '10.908', 'groupId': 'OG000'}]}]}, {'title': 'Whole body: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.48', 'spread': '10.573', 'groupId': 'OG000'}]}]}, {'title': 'Whole Brain: 10 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.54', 'spread': '1.537', 'groupId': 'OG000'}]}]}, {'title': 'Whole Brain: 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.96', 'spread': '1.302', 'groupId': 'OG000'}]}]}, {'title': 'Whole Brain: 2 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.60', 'spread': '1.164', 'groupId': 'OG000'}]}]}, {'title': 'Whole Brain: 4 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.26', 'spread': '1.013', 'groupId': 'OG000'}]}]}, {'title': 'Whole Brain: 5 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.10', 'spread': '0.970', 'groupId': 'OG000'}]}]}, {'title': 'Whole Brain: 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.79', 'spread': '0.651', 'groupId': 'OG000'}]}]}, {'title': 'Whole Brain: 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.08', 'spread': '0.437', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes and 1, 2, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': '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.', 'unitOfMeasure': '%IA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Bladder Content', 'categories': [{'measurements': [{'value': '0.5480', 'spread': '0.07681', 'groupId': 'OG000'}]}]}, {'title': 'Brain', 'categories': [{'measurements': [{'value': '0.6598', 'spread': '0.15464', 'groupId': 'OG000'}]}]}, {'title': 'Gallbladder', 'categories': [{'measurements': [{'value': '0.0466', 'spread': '0.01877', 'groupId': 'OG000'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '1.2551', 'spread': '0.46846', 'groupId': 'OG000'}]}]}, {'title': 'Lower Large Intestine', 'categories': [{'measurements': [{'value': '0.4605', 'spread': '0.16382', 'groupId': 'OG000'}]}]}, {'title': 'Lungs', 'categories': [{'measurements': [{'value': '1.664', 'spread': '0.2683', 'groupId': 'OG000'}]}]}, {'title': 'Remainder', 'categories': [{'measurements': [{'value': '9.409', 'spread': '1.0420', 'groupId': 'OG000'}]}]}, {'title': 'Small Intestine', 'categories': [{'measurements': [{'value': '0.2904', 'spread': '0.10342', 'groupId': 'OG000'}]}]}, {'title': 'Upper Large Intestine', 'categories': [{'measurements': [{'value': '0.5620', 'spread': '0.19993', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': '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.', 'unitOfMeasure': 'becquerel·hour/ becquerel (MBq·h / MBq)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': '10 min', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': '1 hour', 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '2.76', 'spread': '1.96', 'groupId': 'OG000'}]}]}, {'title': '3 hour', 'categories': [{'measurements': [{'value': '4.97', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '6.28', 'spread': '1.52', 'groupId': 'OG000'}]}]}, {'title': '5 hour', 'categories': [{'measurements': [{'value': '8.37', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': '5 to 24 hour', 'categories': [{'measurements': [{'value': '30.15', 'spread': '3.77', 'groupId': 'OG000'}]}]}, {'title': '24 to 48 hour', 'categories': [{'measurements': [{'value': '45.45', 'spread': '8.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes and 1, 2, 3, 4, 5, 5 to 24, and 24 to 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': '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.', 'unitOfMeasure': '%IA (per hour)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'title': 'Adrenals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0157', 'spread': '0.00161', 'groupId': 'OG000'}]}]}, {'title': 'Brain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0217', 'spread': '0.00573', 'groupId': 'OG000'}]}]}, {'title': 'Breasts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0092', 'spread': '0.00098', 'groupId': 'OG000'}]}]}, {'title': 'Gallbladder Wall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0301', 'spread': '0.00540', 'groupId': 'OG000'}]}]}, {'title': 'Heart Wall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0240', 'spread': '0.00478', 'groupId': 'OG000'}]}]}, {'title': 'Kidneys', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0132', 'spread': '0.00150', 'groupId': 'OG000'}]}]}, {'title': 'Liver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0351', 'spread': '0.00838', 'groupId': 'OG000'}]}]}, {'title': 'Lower Large Intestine Wall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0526', 'spread': '0.01653', 'groupId': 'OG000'}]}]}, {'title': 'Lungs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0523', 'spread': '0.00706', 'groupId': 'OG000'}]}]}, {'title': 'Muscle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0111', 'spread': '0.00138', 'groupId': 'OG000'}]}]}, {'title': 'Osteogenic Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0331', 'spread': '0.00504', 'groupId': 'OG000'}]}]}, {'title': 'Ovaries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0205', 'spread': '0.00451', 'groupId': 'OG000'}]}]}, {'title': 'Pancreas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0167', 'spread': '0.00194', 'groupId': 'OG000'}]}]}, {'title': 'Red Marrow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0108', 'spread': '0.00129', 'groupId': 'OG000'}]}]}, {'title': 'Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0069', 'spread': '0.00086', 'groupId': 'OG000'}]}]}, {'title': 'Small Intestine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0263', 'spread': '0.00675', 'groupId': 'OG000'}]}]}, {'title': 'Spleen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0183', 'spread': '0.00550', 'groupId': 'OG000'}]}]}, {'title': 'Stomach Wall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0216', 'spread': '0.00439', 'groupId': 'OG000'}]}]}, {'title': 'Testes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0086', 'spread': '0.00091', 'groupId': 'OG000'}]}]}, {'title': 'Thymus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0123', 'spread': '0.00149', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0166', 'spread': '0.00471', 'groupId': 'OG000'}]}]}, {'title': 'Total Body', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0136', 'spread': '0.00162', 'groupId': 'OG000'}]}]}, {'title': 'Upper Large Intestine Wall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0480', 'spread': '0.01548', 'groupId': 'OG000'}]}]}, {'title': 'Urinary Bladder Wall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0602', 'spread': '0.01423', 'groupId': 'OG000'}]}]}, {'title': 'Uterus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0184', 'spread': '0.00281', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Sex-averaged normalized organ absorbed doses calculated according to Medical Internal Radiation Dose (MIRD) method.', 'unitOfMeasure': 'milligray/becquerel (mGy/MBq)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0280', 'spread': '0.00448', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'The ED per unit of administered activity was evaluated from the ensemble of absorbed dose data.', 'unitOfMeasure': 'millisievert/becquerel (mSv/MBq)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': 'Participants received a single administration of DaTSCAN™ ioflupane (123I) injection by bolus intravenous (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 single photon emission computed tomography (SPECT) imaging was performed at 3 and 6 hours after administration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Safety Population', 'comment': 'The safety population included all participants who received ioflupane (123I) injection.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'DaTSCAN™ Ioflupane (123I) Injection', 'description': '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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'spread': '7.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Chinese', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Mixed race or non-Chinese', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Han Chinese', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety population included all participants who received ioflupane (123I) injection.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-04', 'size': 938674, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-02T09:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2020-07-30', 'resultsFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2020-09-18', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-01', 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline up to 2 weeks after IMP administration (i.e., up to 16 days)', 'description': '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.'}, {'measure': '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)', 'timeFrame': '1 hour before injection (baseline), and at approximately 15 minutes, 1, 4, 24, 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': '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.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings Pre-specified Timepoints', 'timeFrame': 'Baseline, 4 hours after injection and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': '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.'}, {'measure': 'Change From Baseline in Hematology Parameters at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in activated partial thromboplastin time, prothrombin time, thrombin time were reported.'}, {'measure': 'Change From Baseline in Hematology Parameter-C Reactive Protein at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in C reactive protein were reported.'}, {'measure': 'Change From Baseline in Hematology Parameter-Hematocrit at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in hematocrit were reported.'}, {'measure': 'Change From Baseline in Hematology Parameter-Erythrocytes at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in erythrocytes were reported.'}, {'measure': 'Change From Baseline in Hematology Parameters- Leukocytes, Platelets at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in leukocytes, platelets timepoints were reported.'}, {'measure': 'Change From Baseline in Hematology Parameters- Fibrinogen, Hemoglobin at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in fibrinogen, hemoglobin were reported.'}, {'measure': 'Change From Baseline in Serum Chemistry Parameters- Albumin, Protein at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in albumin, protein were reported.'}, {'measure': 'Change From Baseline in Serum Chemistry Parameters- Thyroxine, Free and Triiodothyronine, Free at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Change from baseline in thyroxine, free and triiodothyronine, free were reported.'}, {'measure': 'Change From Baseline in Serum Chemistry Parameters at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.'}, {'measure': 'Change From Baseline in Serum Chemistry Parameters- Thyroxine and Triiodothyronine at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Change from baseline in thyroxine and triiodothyronine were reported.'}, {'measure': 'Change From Baseline in Serum Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, and Urate at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in bilirubin, creatinine, direct bilirubin, and urate were reported.'}, {'measure': 'Change From Baseline in Serum Chemistry Parameters- Bicarbonate, Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, Urea Nitrogen at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in bicarbonate, calcium, chloride, glucose, phosphate, potassium, sodium, urea nitrogen were reported.'}, {'measure': 'Change From Baseline in Serum Chemistry Parameters- Thyrotropin at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Change from baseline in thyrotropin were reported.'}, {'measure': 'Change From Baseline in Serum Chemistry Parameters- Amylase at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Change from baseline in amylase were reported.'}, {'measure': 'Number of Participants With Clinically Significant Abnormal Urinalysis Parameters - pH and Specific Gravity at Pre-specified Timepoints', 'timeFrame': 'Baseline, and at approximately 3 hours, 48 hours, and 2 weeks after DaTSCAN™ ioflupane (123I) injection (i.e., up to 16 days)', 'description': 'Number of participants with clinically significant abnormal pH and specific gravity were reported. Clinical significance was determined by investigator.'}, {'measure': 'Number of Participants Who Reported Abnormal Injection Site Monitoring Findings at Pre-specified Timepoints', 'timeFrame': 'Baseline, up to 4 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Any radiopharmaceutical extravasation, bleeding, hematoma, redness, infection, or other findings were considered as abnormal findings.'}, {'measure': 'Change From Baseline in Vital Sign-Systolic Blood Pressure at Pre-specified Timepoints', 'timeFrame': '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)', 'description': 'Change from baseline in systolic blood pressure were reported.'}, {'measure': 'Change From Baseline in Vital Sign-Diastolic Blood Pressure at Pre-specified Timepoints', 'timeFrame': '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)', 'description': 'Change from baseline in diastolic blood pressure were reported.'}, {'measure': 'Change From Baseline in Vital Sign-Heart Rate at Pre-specified Timepoints', 'timeFrame': '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)', 'description': 'Change from baseline in heart rate were reported.'}, {'measure': 'Change From Baseline in Vital Sign-Temperature at Pre-specified Timepoints', 'timeFrame': '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)', 'description': 'Change from baseline in temperature were reported.'}, {'measure': 'Change From Baseline in Vital Sign-Respiratory Rate at Pre-specified Timepoints', 'timeFrame': '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)', 'description': 'Change from baseline in respiratory rate were reported.'}, {'measure': 'Change From Baseline in Oxygen Saturation at Pre-specified Timepoints', 'timeFrame': '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)', 'description': 'Change from baseline in oxygen saturation were reported.'}, {'measure': 'Change From Baseline in Electrocardiogram (ECG) Findings at Pre-specified Timepoints', 'timeFrame': 'Baseline, 2 and 5 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Change from baseline in PR interval, QRS interval, QT interval, QTC interval, RR interval, QTCF interval, QTCB interval were reported.'}], 'secondaryOutcomes': [{'measure': 'Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Blood (Plasma and Whole Blood)', 'timeFrame': 'Pre-dose, 5, 15, 30 minutes and 1, 2, 3, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': '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.'}, {'measure': 'Biodistribution Measured by Decay Corrected Percentage Injected Activity (%IA) in Whole Body Image', 'timeFrame': '10 minutes and 1, 2, 4, 5, 24, and 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': '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.'}, {'measure': 'Biodistribution by Source Regions Measured by Decay Corrected Normalized Cumulative Activity', 'timeFrame': 'Up to 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': '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.'}, {'measure': 'Biodistribution as Measured by Decay-corrected Cumulative 123I Activity Concentration in Excreted Urine', 'timeFrame': '10 minutes and 1, 2, 3, 4, 5, 5 to 24, and 24 to 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': '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.'}, {'measure': 'Normalized Organ Absorbed Doses as Measured by Radiation Dosimetry', 'timeFrame': 'Up to 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'Sex-averaged normalized organ absorbed doses calculated according to Medical Internal Radiation Dose (MIRD) method.'}, {'measure': 'Effective Dose (ED) of Ioflupane (123I) Injection After IV Administration', 'timeFrame': 'Up to 48 hours after DaTSCAN™ ioflupane (123I) injection', 'description': 'The ED per unit of administered activity was evaluated from the ensemble of absorbed dose data.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Single photon emission computed tomography (SPECT)', 'Healthy Volunteer (HV)'], 'conditions': ['Healthy Subjects (HS)']}, 'referencesModule': {'references': [{'pmid': '37029298', 'type': 'DERIVED', 'citation': 'Zhang M, Wang Y, Wang J, Li X, Li B. Safety, biodistribution and radiation dosimetry of [123I]ioflupane in healthy Chinese volunteers. EJNMMI Res. 2023 Apr 7;13(1):30. doi: 10.1186/s13550-023-00978-3.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label, single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and effective dose of DaTSCAN™ ioflupane (123I) injection in Chinese Healthy Volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese male or female who has agreed to sign and date the written informed consent form\n* Age 18-70 years\n* Body mass index (BMI) of 18-30 kg/m\\^2\n* General good state of health as judged by a qualified physician after completing physical examination\n* Fit, co-operative, and able to provide consent\n\nExclusion Criteria:\n\n* Sensitivity to DaTSCAN™ ioflupane (123I) injection or any of its ingredients\n* A history of motor disturbances\n* A history of pulmonary, cardiovascular, neurological, renal or hepatic, hormonal or coagulation disorders or hyperthyroidism\n* A history of drug, alcohol, or solvent abuse\n* The subject has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening\n* Radionuclide injection within a minimum of 5 radioactive half-lives prior to screening\n* Use of any medication (except paracetamol \\[acetaminophen\\] or oral contraceptive), including traditional Chinese medicine, within 2 weeks prior to the imaging visit\n* Classification as a radiation worker\n* Women of child-bearing potential not accepting a highly effective method of birth control (A woman is considered of child-bearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Postmenopausal is defined as 12 months with no menses without an alternative medical cause, in International Council on Harmonisation (ICH) M3 (R2); A highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner, in ICH M3 (R2).\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT04564092', 'briefTitle': 'A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'A Phase 1, Non-randomised, Noncomparative, Open-label Study to Assess the Safety, Biodistribution, and Internal Radiation Dosimetry of a Single Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers', 'orgStudyIdInfo': {'id': 'GE-001-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DaTSCAN™ ioflupane (123I) injection', 'description': 'Participants will receive a single intravenous (IV) injection of DaTSCAN™ ioflupane (123I) injection into an arm vein, followed by planar whole-body imaging at prespecified time points over a period of 48 hours after administration. Brain SPECT imaging will be acquired at 3 and 6 hours after administration.', 'interventionNames': ['Drug: DaTSCAN™ Ioflupane (123I) Injection']}], 'interventions': [{'name': 'DaTSCAN™ Ioflupane (123I) Injection', 'type': 'DRUG', 'otherNames': ['Ioflupane (123I)'], 'description': 'Each participant will receive a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV injection with a nominal iodine (123I) activity of 111 MBq ±10%, in a maximum volume of 5 mL.', 'armGroupLabels': ['DaTSCAN™ ioflupane (123I) injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Huangpu', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Rujin hospital, affiliated to Shanghai Jiaotong University, School of Medicine', 'geoPoint': {'lat': 31.2378, 'lon': 121.4781}}], 'overallOfficials': [{'name': 'Biao LI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rujin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PPD Development, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}