Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-02-21 @ 2:53 PM
Study NCT ID:
NCT01956032
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2013-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie (prior sponsor, Abbott)'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From signing of informed consent until 30 days or 5 half-lives from the last dose of Duodopa treatment or up to approximately 45 days', 'description': 'Only serious adverse events (SAEs) were assessed. There were no SAEs reported during the conduct of this study.', 'eventGroups': [{'id': 'EG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.", 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Participant + Investigator: All Types (N=12)', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '39.0'}]}]}, {'title': 'Participant + Investigator: TM (N=12)', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '39.0'}]}]}, {'title': 'Participant + Investigator: Telephone (N=1)', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '30.0'}]}]}, {'title': 'Participant + Investigator: Home Visit (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Participant + Investigator: Other (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Participant + DNS: All Types', 'categories': [{'measurements': [{'value': '317.4', 'groupId': 'OG000', 'lowerLimit': '130.0', 'upperLimit': '558.0'}]}]}, {'title': 'Participant + DNS: TM', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '97.0'}]}]}, {'title': 'Participant + DNS: Telephone (N=8)', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '46.0'}]}]}, {'title': 'Participant + DNS: Home Visit', 'categories': [{'measurements': [{'value': '280.8', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '437.0'}]}]}, {'title': 'Participant + DNS: Other (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Participant + Investigator + DNS: All Types', 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '77.0'}]}]}, {'title': 'Participant + Investigator + DNS: TM', 'categories': [{'measurements': [{'value': '42.0', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '77.0'}]}]}, {'title': 'Participant + Investigator + DNS: Telephone (N=1)', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '7.2'}]}]}, {'title': 'Participant + Investigator + DNS: Home Visit (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Participant + Investigator + DNS: Other (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Participant + TM Technician: All Types', 'categories': [{'measurements': [{'value': '100.2', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '240.0'}]}]}, {'title': 'Participant + TM Technician: TM (N=1)', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '1.8'}]}]}, {'title': 'Participant + TM Technician: Telephone (N=1)', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '4.2'}]}]}, {'title': 'Participant + TM Technician: Home Visit', 'categories': [{'measurements': [{'value': '100.2', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '240.0'}]}]}, {'title': 'Participant + TM Technician: Other (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Total DNS: All Types', 'categories': [{'measurements': [{'value': '349.2', 'groupId': 'OG000', 'lowerLimit': '166.0', 'upperLimit': '603.0'}]}]}, {'title': 'Total DNS: TM', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000', 'lowerLimit': '41.0', 'upperLimit': '132.0'}]}]}, {'title': 'Total DNS: Telephone (N=8)', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '50.0'}]}]}, {'title': 'Total DNS: Home Visit', 'categories': [{'measurements': [{'value': '280.8', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '437.0'}]}]}, {'title': 'Total DNS: Other (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Total Investigator: All Types', 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '112.0'}]}]}, {'title': 'Total Investigator: TM', 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '112.0'}]}]}, {'title': 'Total Investigator: Telephone (N=1)', 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000', 'lowerLimit': '37.2', 'upperLimit': '37.2'}]}]}, {'title': 'Total Investigator: Home Visit (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Total Investigator: Other (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Total Participant: All Types', 'categories': [{'measurements': [{'value': '532.8', 'groupId': 'OG000', 'lowerLimit': '251.0', 'upperLimit': '878.0'}]}]}, {'title': 'Total participant: TM', 'categories': [{'measurements': [{'value': '100.2', 'groupId': 'OG000', 'lowerLimit': '43.0', 'upperLimit': '171.0'}]}]}, {'title': 'Total Participant: Telephone (N=8)', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '80.0'}]}]}, {'title': 'Total Participant: Home Visit', 'categories': [{'measurements': [{'value': '345.0', 'groupId': 'OG000', 'lowerLimit': '165.0', 'upperLimit': '677.0'}]}]}, {'title': 'Total Participant: Other (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using full analysis set (FAS), defined as all participants that started Duodopa titration.'}, {'type': 'PRIMARY', 'title': 'Median Number of Contacts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Total Contact With Participant: All Types', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '37.0'}]}]}, {'title': 'Total Contact With Participant: TM', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '23.0'}]}]}, {'title': 'Total Contact With Participant: Telephone', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '11.0'}]}]}, {'title': 'Total Contact With Participant: Home Visit', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '6.0'}]}]}, {'title': 'Total Contact With Participant: Other', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Participant + Investigator: All Types', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.0'}]}]}, {'title': 'Participant + Investigator: TM', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.0'}]}]}, {'title': 'Participant + Investigator: Telephone', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}, {'title': 'Participant + Investigator: Home Visit', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Participant + Investigator: Other', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Participant + DNS: All Types', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '22.0'}]}]}, {'title': 'Participant + DNS: TM', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '12.0'}]}]}, {'title': 'Participant + DNS: Telephone', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.0'}]}]}, {'title': 'Participant + DNS: Home Visit', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': 'Participant + DNS: Other', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Participant + Investigator + DNS: All Types', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '11.0'}]}]}, {'title': 'Participant + Investigator + DNS: TM', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '11.0'}]}]}, {'title': 'Participant + Investigator + DNS: Telephone', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Participant + Investigator + DNS: Home Visit', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Participant + Investigator + DNS: Other', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Participant + TM Technician: All Types', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Participant + TM Technician: TM', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Participant + TM Technician: Telephone', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Participant + TM Technician: Home Visit', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}, {'title': 'Participant + TM Technician: Other', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.', 'unitOfMeasure': 'Number of contacts', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Median Total Time for Titration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'categories': [{'measurements': [{'value': '4093.2', 'groupId': 'OG000', 'lowerLimit': '2850.0', 'upperLimit': '19925.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': "From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator's decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range.", 'unitOfMeasure': 'Minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Median Total Free Time of Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'categories': [{'measurements': [{'value': '3865.2', 'groupId': 'OG000', 'lowerLimit': '2458.0', 'upperLimit': '13659.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': "From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "Participant's daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant's daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant's total free time was calculated as the sum of participant's daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range.", 'unitOfMeasure': 'Minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Technical Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Any Technical Event', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Failure to Answer Video Call', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Other', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Intentional Failure to Answer Video Call', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Other', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Mechanical', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Electrical', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Other', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Failure to Establish Connection', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Interruptions', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Transmission Quality', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Sound Quality', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Image Quality', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Other', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Incidence of Technical Events Experienced by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Any Technical Event (N=11)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Failure to Answer Video Call (AVC) (N=2)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Other (N=1)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Intentional Failure to AVC (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Other (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Mechanical (N=2)', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Electrical (N=3)', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Other (N=5)', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Failure to Establish Connection (N=6)', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Interruptions (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Transmission Quality (N=2)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Sound Quality (N=5)', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Image Quality (N=1)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Other (N=1)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34).', 'unitOfMeasure': 'Percentage of technical events', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Consequences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Any Consequence', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}]}]}, {'title': 'Contact Delay: Type A', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Contact Delay: Type B', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Contact Delay: Type C', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Contact Delay: Type D', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Re-establishment of Connection: Type A', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Re-establishment of Connection: Type B', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Re-establishment of Connection: Type C', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Re-establishment of Connection: Type D', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'TM-call Replaced by Telephone Call: Type A', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'TM-call Replaced by Telephone Call: Type B', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'TM-call Replaced by Telephone Call: Type C', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'TM-call Replaced by Telephone Call: Type D', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}, {'title': 'Failed Scheduled Contact: Type A', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Failed Scheduled Contact: Type B', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Failed Scheduled Contact: Type C', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Failed Scheduled Contact: Type D', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Other Consequence: Type A', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Other Consequence: Type B', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Other Consequence: Type C', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Other Consequence: Type D', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Incidence of Consequences Due to Technical Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Any Consequence (N=11)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Contact Delay: Type A (N=1)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Contact Delay: Type B (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Contact Delay: Type C (N=3)', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}]}]}, {'title': 'Contact Delay: Type D (N=3)', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'Re-establishment of Connection: Type A (N=1)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Re-establishment of Connection: Type B (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Re-establishment of Connection: Type C (N=4)', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}]}]}, {'title': 'Re-establishment of Connection: Type D (N=5)', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}]}]}, {'title': 'TM-call Replaced by Telephone Call: Type A (N=3)', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}]}]}, {'title': 'TM-call Replaced by Telephone Call: Type B (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'TM-call Replaced by Telephone Call: Type C (N=4)', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'TM-call Replaced by Telephone Call: Type D (N=7)', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}]}]}, {'title': 'Failed Scheduled Contact: Type A (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Failed Scheduled Contact: Type B (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Failed Scheduled Contact: Type C (N=2)', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'Failed Scheduled Contact: Type D (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Other Consequence: Type A (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Other Consequence: Type B (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Other Consequence: Type C (N=2)', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}]}]}, {'title': 'Other Consequence: Type D (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43).', 'unitOfMeasure': 'Percentage of consequences', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Any Technical Event', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Contact Delay', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Re-establishment of Connection', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Type A: TM-call Replaced by Telephone Call', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Failed Scheduled Contact Failure', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Other Consequence', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Contact Delay', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Re-establishment of Connection', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type B: TM-call Replaced by Telephone Call', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Failed Scheduled Contact Failure', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Other Consequence', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Contact Delay', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Re-establishment of Connection', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Type C: TM-call Replaced by Telephone Call', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Failed Scheduled Contact Failure', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Other Consequence', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Contact Delay', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Re-establishment of Connection', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Type D: TM-call Replaced by Telephone Call', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Failed Scheduled Contact Failure', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Other Consequence', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Any Technical Event (N=11)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Contact Delay (N=1)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Re-establishment of Connection (N=1)', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Type A: TM-call Replaced by Telephone Call (N=3)', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Failed Scheduled Contact Failure (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Type A: Other Consequence (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Contact Delay (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Re-establishment of Connection (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Type B: TM-call Replaced by Telephone Call (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Failed Scheduled Contact Failure (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Type B: Other Consequence (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Contact Delay (N=3)', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Re-establishment of Connection (N=4)', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Type C: TM-call Replaced by Telephone Call (N=4)', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Failed Scheduled Contact Failure (N=2)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'Type C: Other Consequence (N=2)', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Contact Delay (N=3)', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Re-establishment of Connection (N=5)', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}]}]}, {'title': 'Type D: TM-call Replaced by Telephone Call (N=7)', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Failed Scheduled Contact Failure (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Type D: Other Consequence (N=0)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data were not available due to zero participants analyzed.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34).', 'unitOfMeasure': 'Percentage of technical events', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Dissatisfied)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Satisfied)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Hard)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Easy)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Dissatisfied)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Satisfied)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Dissatisfied)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Satisfied)', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Dissatisfied)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Satisfied)', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Dissatisfied)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Satisfied)', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Dissatisfied)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Satisfied)', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': "Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?", 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Dissatisfied)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Satisfied)', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician's visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Unconfident)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Confident)', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Unsecure)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Secure)', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure' and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': "Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Dissatisfied)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Satisfied)', 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant's home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 14 (Where you able to perform daily activities during the titration period?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Unconfident)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Confident)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days. The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 4', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 6', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 5', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 6', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 5', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 6', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 7--Very Satisfied', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 4', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 6', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 7--Very Satisfied', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 3', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 5', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 6', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 4', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 5', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 6', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 3', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 5', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 6', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 5', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 6', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 3', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 4', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 5', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 6', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 4', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 5', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 6', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 5', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 6', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 5', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 6', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 5', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 6', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 2', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 5', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 6', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 5', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 6', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 3', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 5', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 6', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 5', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 6', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 1-Very Dissatisfied', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 4', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 5', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 6', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Scale 7-Very Satisfied', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'yes' or 'no' for question number 10 (Did you lack any dimensions in the assessment of the participant using TM that you have in the classical titration at hospital?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: More', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Equal', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Less', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: More', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Equal', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Less', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 11 (Compared to classic titration at hospital - how much time did you spend on TM communication based on real communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: More', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Equal', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Less', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: More', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Equal', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Less', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 12 (Compared to classic titration at hospital - how much time did you spend on TM communication based on booked communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Investigator Experience: More', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Equal', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Investigator Experience: Less', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: More', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Equal', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'DNS Experience: Less', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 13 (Compared to classic titration at hospital - how much time did you spend on TM communication based on time for other tasks between contacts?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Scale 1 (Very Dissatisfied)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 4', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Scale 5', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Scale 6', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Scale 7 (Very Satisfied)', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms", 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Very Much Improved', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}]}]}, {'title': 'Minimally Improved', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Minimally Worse', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Very Much Worse', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "CGI-I was used to document the Investigator's impression of the participant's improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'General Practitioner', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Emergency Ward', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other Neurologist', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other).', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Telephone', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Home or Outpatient Visit', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hospitalization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization).', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS, defined as all participants that started Duodopa titration.'}, {'type': 'SECONDARY', 'title': 'Median Time Spent for Health Care Utilization Outside the TM Care Chain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'classes': [{'categories': [{'measurements': [{'value': '190.8', 'groupId': 'OG000', 'lowerLimit': '190.8', 'upperLimit': '190.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using FAS with non-missing information.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': "Participants With Parkinson's Disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'spread': '6.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-25', 'studyFirstSubmitDate': '2013-09-30', 'resultsFirstSubmitDate': '2015-11-06', 'studyFirstSubmitQcDate': '2013-09-30', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-16', 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.'}, {'measure': 'Median Number of Contacts', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.'}], 'secondaryOutcomes': [{'measure': 'Median Total Time for Titration', 'timeFrame': "From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator's decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range."}, {'measure': 'Median Total Free Time of Participant', 'timeFrame': "From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "Participant's daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant's daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant's total free time was calculated as the sum of participant's daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range."}, {'measure': 'Percentage of Participants Who Experienced Technical Events', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population.'}, {'measure': 'Incidence of Technical Events Experienced by Participants', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34).'}, {'measure': 'Percentage of Participants With Consequences', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population.'}, {'measure': 'Incidence of Consequences Due to Technical Events', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43).'}, {'measure': 'Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population.'}, {'measure': 'Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34).'}, {'measure': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': "Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?", 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician's visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure' and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information."}, {'measure': "Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?", 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant's home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 14 (Where you able to perform daily activities during the titration period?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days. The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'yes' or 'no' for question number 10 (Did you lack any dimensions in the assessment of the participant using TM that you have in the classical titration at hospital?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 11 (Compared to classic titration at hospital - how much time did you spend on TM communication based on real communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 12 (Compared to classic titration at hospital - how much time did you spend on TM communication based on booked communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 13 (Compared to classic titration at hospital - how much time did you spend on TM communication based on time for other tasks between contacts?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': "Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms", 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': "CGI-I was used to document the Investigator's impression of the participant's improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information."}, {'measure': 'Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other).'}, {'measure': 'Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization).'}, {'measure': 'Median Time Spent for Health Care Utilization Outside the TM Care Chain', 'timeFrame': "From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days", 'description': 'The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LCIG', "Parkinson's disease", 'levodopa carbidopa intestinal gel', 'Telemedicine'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the use of resources during titration of Duodopa at home.', 'detailedDescription': 'Telemedicine (TM) offers an alternative titration procedure allowing the start of Duodopa infusion at home. The study evaluated the use of resources, measured as the number of contacts and time spent by health care professionals (Duodopa nurse specialists and the study Investigators) and the TM technician, during Duodopa infusion at home. Data was collected from four (4) clinical centers in Sweden. Data collection period for each participant started at the decision to administer Duodopa treatment (Baseline) and ended when the Duodopa titration period was complete. Post-titration, the participants and caregiver were interviewed and the investigators and nurses answered a web based questionnaire on their experiences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Participants with advanced Parkinson's disease admitted to movement disorder specialty clinics", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Suitable for Duodopa treatment in accordance with the Swedish Summary of Product Characteristics\n2. Motivated and confident to test Duodopa home titration using TM\n3. Participants who were able to handle the infusion pump and the TM equipment by themselves or with assistance, as determined by the Investigator\n4. Understood and signed the study informed consent form\n\nExclusion Criteria:\n\n1. Dementia or cognitive decline with Mini Mental State Examination score less than 24\n2. Ongoing symptomatic depression, hallucinations or other psychotic behaviors without adequate treatment, as determined by the Investigator\n3. Contraindications as described in the Swedish Summary of Product Characteristics: hypersensitivity to levodopa or carbidopa, narrow angle glaucoma, serious liver and kidney disease, severe heart failure, acute myocardial infarction, severe cardiac arrhythmias, recent or acute stroke, contraindications for adrenergic effects; pheochromocytoma, hyperthyroidism, cushing's syndrome, and other contraindications for abdominal surgery\n4. Other reasons that made the participant unsuitable for home titration using TM, as determined by the Investigator"}, 'identificationModule': {'nctId': 'NCT01956032', 'briefTitle': 'Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Levodopa Carbidopa Intestinal Gel Home Titration Using Telemedicine: Evaluation of Use of Resources', 'orgStudyIdInfo': {'id': 'P14-000'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Participants with Parkinson's disease", 'description': "Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.\n\nOther name for Duodopa is Levodopa Carbidopa Intestinal Gel (LCIG)."}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eva Dahl, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}