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  1. 1. Klinische Studie
  2. 2. Routinedokumentation
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TRR295 Retune Core Data Set - Basisdaten Baseline

- 09.10.23 - 37 Formulare, 1 Itemgruppe, 92 Datenelemente, 2 Sprachen
Itemgruppe: Basisdaten Baseline
DRKS-ID der Studie: DRKS00028750 Allgemeinverständliche Kurzbeschreibung Die zentrale Patientenkohorte des SFB/TR ReTune beinhaltet einen klinischen Kerndatensatz von Patienten mit Parkinson, Tremor oder Dystonie. Sie dient als eine Informationsplattform, um Effekte der Behandlung mit Tiefen Hirnstimulation auf die Patient:innen mit unterschiedlichen Erkrankungen zu untersuchen.

Endpunkte Baseline

1 Itemgruppe 21 Datenelemente

Basisdaten Baseline

1 Itemgruppe 92 Datenelemente

Basisdaten FU 12 Mon

1 Itemgruppe 61 Datenelemente

Operations Details

1 Itemgruppe 8 Datenelemente

Endpunkte Follow-up

1 Itemgruppe 24 Datenelemente

Endpunkte Follow-up

1 Itemgruppe 24 Datenelemente

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Week 28

- 06.11.17 - 1 Formular, 7 Itemgruppen, 29 Datenelemente, 1 Sprache
Itemgruppen: Vital signs, Healthcare resource utilisation - Visits/Contacts with Physicians, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Patient Rated Scales, Ramos Randomisation and Dispensing
Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Week 28

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Week 12

- 06.11.17 - 1 Formular, 6 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: Vital signs, Healthcare resource utilisation - Visits/Contacts with Physicians, Healthcare resource utilisation - Visits/Contacts with other Paramedical Practitioners, Healthcare resource utilisation - Hospitalisation, Healthcare resource utilisation - accident & emergency / emergency room visits, Patient Rated Scales
Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Week 12

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Concomitant Medication

- 06.11.17 - 1 Formular, 1 Itemgruppe, 7 Datenelemente, 1 Sprache
Itemgruppe: Concomitant Medication
Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Concomitant Medication (Follow-Up)

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Mandatory 7 Day Follow Up Assessment

- 06.11.17 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache
Itemgruppen: Vital signs, Laboratory Evaluation
Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Mandatory 7 Day Follow Up Assessment

ICHOM Parkinson's Disease - Baseline and annual Clinical Form

- 30.04.20 - 1 Formular, 2 Itemgruppen, 3 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Cognitive and psychiatric functioning
PARKINSON‘S DISEASE DATA COLLECTION Version 2.2.1 Revised April 10th, 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions Covered: Idiopathic Parkinson’s Disease Treatment Approaches: Pharmacotherapy | Behavioral Therapy | Exercise-Based Therapy | Deep Brain Stimulation | Infusion/Injection-Based Delivery This ODM-file contains clinical variables to be administered at baseline and annually from then on. Surveys used: Movement Disorder Society (MDS-UPDRS), Part I: Non-Motor Aspects of Experiences of Daily Living (nM- EDL). Both clinical- and patient-reported portions; Part II: Motor Aspects of Experiences of Daily Living (M-EDL). Patient-reported: The MDS-UPDRS requires a license (by International Parkinson’s and Movement Disorders Society), therefore the used items are not integrated into this version of the Parkinson's Disease Standard Set. International Parkinson’s and Movement Disorders Society (IPMDS) Non-motor symptoms questionnaire (NMSQ): The NMSQ requires a license. However, in ICHOM's Parkinson's Disease Standard Set only one question derived from 2 NMSQ items is used. Parkinson’s Disease Quality of Life Questionnaire (PDQ-8): The PDQ-8 requires a license (by Innovation, Oxford University), therefore the used items are not integrated into this version of the Parkinson's Disease Standard Set. ICHOM was supported for this standard set by the International Association for Parkinsonism and Related Disorders. Publication: De Roos P, Bloem BR, Kelley TA, et al. A Consensus Set of Outcomes for Parkinson’s Disease from the International Consortium for Health Outcomes Measurement. Journal of Parkinson’s disease. 2017;7(3):533-543. doi:10.3233/JPD-161055. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Parkinson's Disease - Annual Clinical Form: Treatment variables

- 30.04.20 - 1 Formular, 2 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Treatment Variables
PARKINSON‘S DISEASE DATA COLLECTION Version 2.2.1 Revised April 10th, 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions Covered: Idiopathic Parkinson’s Disease Treatment Approaches: Pharmacotherapy | Behavioral Therapy | Exercise-Based Therapy | Deep Brain Stimulation | Infusion/Injection-Based Delivery This ODM-file contains clinically reported Treatment variables to be administered annually. Surveys used: Movement Disorder Society (MDS-UPDRS), Part I: Non-Motor Aspects of Experiences of Daily Living (nM- EDL). Both clinical- and patient-reported portions; Part II: Motor Aspects of Experiences of Daily Living (M-EDL). Patient-reported: The MDS-UPDRS requires a license (by International Parkinson’s and Movement Disorders Society), therefore the used items are not integrated into this version of the Parkinson's Disease Standard Set. International Parkinson’s and Movement Disorders Society (IPMDS) Non-motor symptoms questionnaire (NMSQ): The NMSQ requires a license. However, in ICHOM's Parkinson's Disease Standard Set only one question derived from 2 NMSQ items is used. Parkinson’s Disease Quality of Life Questionnaire (PDQ-8): The PDQ-8 requires a license (by Innovation, Oxford University), therefore the used items are not integrated into this version of the Parkinson's Disease Standard Set. ICHOM was supported for this standard set by the International Association for Parkinsonism and Related Disorders. Publication: De Roos P, Bloem BR, Kelley TA, et al. A Consensus Set of Outcomes for Parkinson’s Disease from the International Consortium for Health Outcomes Measurement. Journal of Parkinson’s disease. 2017;7(3):533-543. doi:10.3233/JPD-161055. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Parkinson's Disease - Baseline and annually patient-reported Form

- 30.04.20 - 1 Formular, 6 Itemgruppen, 28 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, Demographic factors, Baseline clinical status, Non-motor aspects of experiences of daily living, Motor aspects of experiences of daily living, Overall health status
PARKINSON‘S DISEASE DATA COLLECTION Version 2.2.1 Revised April 10th, 2017 www.ichom.org Notice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions Covered: Idiopathic Parkinson’s Disease Treatment Approaches: Pharmacotherapy | Behavioral Therapy | Exercise-Based Therapy | Deep Brain Stimulation | Infusion/Injection-Based Delivery This ODM-file contains patient-reported variables to be administered at baseline and annually from then on. Surveys used: Movement Disorder Society (MDS-UPDRS), Part I: Non-Motor Aspects of Experiences of Daily Living (nM- EDL). Both clinical- and patient-reported portions; Part II: Motor Aspects of Experiences of Daily Living (M-EDL). Patient-reported: The MDS-UPDRS requires a license (by International Parkinson’s and Movement Disorders Society), therefore the used items are not integrated into this version of the Parkinson's Disease Standard Set. International Parkinson’s and Movement Disorders Society (IPMDS) Non-motor symptoms questionnaire (NMSQ): The NMSQ requires a license. However, in ICHOM's Parkinson's Disease Standard Set only one question derived from 2 NMSQ items is used. Parkinson’s Disease Quality of Life Questionnaire (PDQ-8): The PDQ-8 requires a license (by Innovation, Oxford University), therefore the used items are not integrated into this version of the Parkinson's Disease Standard Set. ICHOM was supported for this standard set by the International Association for Parkinsonism and Related Disorders. Publication: De Roos P, Bloem BR, Kelley TA, et al. A Consensus Set of Outcomes for Parkinson’s Disease from the International Consortium for Health Outcomes Measurement. Journal of Parkinson’s disease. 2017;7(3):533-543. doi:10.3233/JPD-161055. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Parkinson's Disease - First Doctor's Visit Form

- 30.04.20 - 1 Formular, 3 Itemgruppen, 8 Datenelemente, 1 Sprache
Itemgruppen: Patient ID, Demographic factors, Baseline clinical status
PARKINSON‘S DISEASE DATA COLLECTION Version 2.2.1 Revised April 10th, 2017 www.ichom.org otice: This work was conducted using resources from ICHOM, the International Consortium for Health Outcomes Measurement (www.ICHOM.org). The content is solely the responsibility of the authors and does not necessarily represent the official views of ICHOM. Conditions Covered: Idiopathic Parkinson’s Disease Treatment Approaches: Pharmacotherapy | Behavioral Therapy | Exercise-Based Therapy | Deep Brain Stimulation | Infusion/Injection-Based Delivery This ODM-file contains a form to be administered at the first visit to the doctor with Parkinson's disease. Mainly Patient-reported, some items may alternatively have a clinical reporting source. Surveys used: Movement Disorder Society (MDS-UPDRS), Part I: Non-Motor Aspects of Experiences of Daily Living (nM- EDL). Both clinical- and patient-reported portions; Part II: Motor Aspects of Experiences of Daily Living (M-EDL). Patient-reported: The MDS-UPDRS requires a license (by International Parkinson’s and Movement Disorders Society), therefore the used items are not integrated into this version of the Parkinson's Disease Standard Set. International Parkinson’s and Movement Disorders Society (IPMDS) Non-motor symptoms questionnaire (NMSQ): The NMSQ requires a license. However, in ICHOM's Parkinson's Disease Standard Set only one question derived from 2 NMSQ items is used. Parkinson’s Disease Quality of Life Questionnaire (PDQ-8): The PDQ-8 requires a license (by Innovation, Oxford University), therefore the used items are not integrated into this version of the Parkinson's Disease Standard Set. ICHOM was supported for this standard set by the International Association for Parkinsonism and Related Disorders. Publication: De Roos P, Bloem BR, Kelley TA, et al. A Consensus Set of Outcomes for Parkinson’s Disease from the International Consortium for Health Outcomes Measurement. Journal of Parkinson’s disease. 2017;7(3):533-543. doi:10.3233/JPD-161055. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

Follow-Up Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

- 17.09.21 - 1 Formular, 8 Itemgruppen, 102 Datenelemente, 1 Sprache
Itemgruppen: Subject Information, Physical Examination, Pregnancy Test (Complete for Female Subjects Only), Vital Signs, 12-Lead ECG, Local laboratory result data (Haematology), Local laboratory result data - (Clinical Chemistry), Urinalysis
Documentation Part: Follow-Up An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Unscheduled Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

- 21.04.17 - 1 Formular, 12 Itemgruppen, 150 Datenelemente, 1 Sprache
Itemgruppen: Subject Information, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities: A. Rhythm, 12-Lead ECG Abnormalities: B. P-Wave and QRS Morphology, 12-Lead ECG Abnormalities: C. Conduction, 12-Lead ECG Abnormalities: D. Myocardial Infarction, 12-Lead ECG Abnormalities: E. Depolarisation/Repolarisation (QRS-T), 12-Lead ECG Abnormalities: Other Abnormalities, Pharmacokinetics - Blood, Local laboratory result data (Haematology), Local laboratory result data - (Clinical Chemistry), Urinalysis
Documentation Part: Unscheduled An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Pregnancy Notification Form (Subject) Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

- 10.04.17 - 1 Formular, 6 Itemgruppen, 44 Datenelemente, 1 Sprache
Itemgruppen: Subject Information, Mother's relevant medical/family history, Father's Relevant Medical/Family History, Drug Exposures, Subject withdrawal, Reporting Investigator Information
Documentation Part: Pregnancy Notification Form (Subject) An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

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