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PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

- 2017-06-08 - 1 Formulär, 2 Item-grupper, 4 Dataelement, 1 Språk
Item-grupper: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES RetDQoL (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

- 2017-06-08 - 1 Formulär, 2 Item-grupper, 4 Dataelement, 1 Språk
Item-grupper: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 2017-06-08 - 1 Formulär, 2 Item-grupper, 4 Dataelement, 1 Språk
Item-grupper: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

PATIENT REPORTED OUTCOME AND QUESTIONNAIRES RetDQoL (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 2017-06-08 - 1 Formulär, 2 Item-grupper, 4 Dataelement, 1 Språk
Item-grupper: Patient administration, PATIENT REPORTED OUTCOME AND QUESTIONNAIRES (DAY 0)
Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Language Used for Patient- Reported Outcome Questionnaires Day 0 Ranibizumab Macular Edema Secondary To Branch Retinal Vein Occlusion FVF4165g - Language Used for Patient- Reported Outcome Questionnaires Day 0

- 2018-03-18 - 1 Formulär, 1 Item-grupp, 4 Dataelement, 1 Språk
Item-grupp: language
Study part: Language Used for Patient- Reported Outcome Questionnaires Day 0. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection Compared With Sham In Subjects with Macular Edema Secondary To Branch Retinal Vein Occlusion.

SF-36 (RAND)

- 2021-09-17 - 1 Formulär, 7 Item-grupper, 36 Dataelement, 1 Språk
Item-grupper: General Info, Current health limitations, Physical Health related problems during past 4 weeks, Emotional problems during past 4 weeks, Past 4 weeks, Emotions in past 4 weeks, General statements
This document contains the 36-Item Short Form Survey Instrument Version 1 (SF-36) form, developed at RAND as part of the Medical Outcomes Study. RAND owns the copyright. All of the surveys and tools from RAND Health are public documents, available without charge. For more information - e.g. on terms and conditions for use or scoring instructions: https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form.html Changes made to the questionnaire should be made clearly identifiable.

ICHOM Heart Failure - Patient-reported Outcome

- 2020-04-30 - 1 Formulär, 3 Item-grupper, 7 Dataelement, 1 Språk
Item-grupper: Administrative Data, Degree of Health, Burden of Care
HEART FAILURE DATA COLLECTION Version 1.1.4 Revised October 31st, 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: Heart Failure Treatment Approaches: Pharmacotherapy | Invasive Therapy | Rehabilitation This ODM-file contains patient-reported outcome variables. It should be tracked 6-monthly for life, starting 30 days and 6 months post-index event. The collection rhythm has to be reset after an acute admission (including complications), starting anew at 30 days post-discharge and 6 months post-hospital admission, and tracked 6-monthly from then on. Use of the following Scores for this standard set: KCCQ-12: Kansas City Cardiomyopathy Questionnaire-Short Version: You can obtain a license to use this instrument at your institution by visiting http://cvoutcomes.org/licenses NYHA – New York Heart Association Functional Classification: The NYHA is free for all health care organizations, and a license is not needed. PROMIS Physical Function Short Form 4a – Patient-Reported Outcome Measurement Information System: PROMIS Physical Function is free for all health care organizations, and a license is not needed. For more information, please visit http://www.healthmeasures.net/explore-measurement-systems/promis/obtain-administer-measures . As http://www.nihpromis.org/ is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. Patient Health Questionnaire (PHQ-2): Copyright by Pfizer: "content found on the PHQ Screeners site is free for download and use as stated within the PHQ Screeners site, please visit http://www.phqscreeners.com/ for more information. ICHOM was supported for the Heart Failure Standard Set by GIG Cymru NHS Wales, American Heart Association, British Heart Foundation, Heart Failure Association of the ESC and European Society of Cardiology. Publication: Burns DJP, Arora J, Okunade O, Beltrame JF, Bernardez-Pereira S, Crespo-Leiro MG, et al. International Consortium for Health Outcomes Measurement (ICHOM): Standardized Patient-Centered Outcomes Measurement Set for Heart Failure Patients. JACC: Heart Failure. 2020 Mar 1;8(3):212–22. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Chronic Kidney Disease - Patient-reported Outcome

- 2020-04-30 - 1 Formulär, 2 Item-grupper, 41 Dataelement, 1 Språk
Item-grupper: Administrative Data, Patient-Reported Health and Wellbeing
CHRONIC KIDNEY DISEASE DATA COLLECTION Version 1.0.0 Revised October 25th, 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: Chronic Kidney Disease Stage G3a/A3 | Chronic Kidney Disease StageG 3b/A2/A3 | Chronic Kidney Disease Stage G4 | Chronic Kidney Disease Stage G5 (KDIGO 2012 Stages) Treatment Approaches: Pre-RRT = Pre-Renal Replacement Therapy | HD = Haemodialysis | PD = Peritoneal Dialysis | Tx = Renal Transplantation | CC = Conservative Care This ODM-file contains patient reported outcome variables, to be collected at baseline and 6-monthly (HD, PD and CC) or annually (Pre-RRT and Tx) after that, from the following surveys: PROMIS-Global Health and PROMIS-29: Free for use in clinical practice. As http://www.nihpromis.org/ is the official distribution site for PROMIS questionnaires and translations, only the total score will be included in this version of the standard set. RAND-36: The RAND 36-Item Short Form Survey (SF-36) was developed at RAND as part of the Medical Outcomes Study: https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html . Publication: Verberne WR, Das-Gupta Z, Allegretti AS, et al. Development of an International Standard Set of Value-Based Outcome Measures for Patients With Chronic Kidney Disease: A Report of the International Consortium for Health Outcomes Measurement (ICHOM) CKD Working Group. American Journal of Kidney Diseases. Volume 73, Issue 3, 2019, Pages 372-384, ISSN 0272-6386, https://doi.org/10.1053/j.ajkd.2018.10.007 ICHOM was supported for the Chronic Kidney Disease Standard Set by NSW Agency for Clinical Innovation, Providence Health and Services, ERCPA, santeon and Dutch Kidney Foundation. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

ICHOM Low Back Pain - Patient-reported Outcome Variables

- 2020-04-30 - 1 Formulär, 4 Item-grupper, 17 Dataelement, 1 Språk
Item-grupper: Administrative Data, Acute Complications of Treatment, Disease Recurrence, Patient-Reported Health Status
LOW BACK PAIN DATA COLLECTION Version 2.0.3 Revised August 24th, 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: Lumbar Disc Herniation | Lumbar Stenosis | Lumbar Spondylolisthesis | Degenerative Scoliosis | Adult Idiopathic Scoliosis | Degenerative Disc Disorder | Other Degenerative Lumbar Disorders | Mechanical, Acute, and Chronic Lumbar Back Pain and Back-Related Leg Pain Conditions Not Covered: Individuals < 18 Years of Age | Spinal Infection | Spinal Tumor | Spinal Fractures | Traumatic Dislocation | Congenital Scoliosis Documented as >20 Degrees, Moderate, Large, or Severe Treatment Approaches: Conservative Therapy (e.g. physical therapy, chiropractic, drug therapy, injections, etc.) | Surgical Therapy (e.g. spinal fusion, decompression, or discectomy) This ODM-file contains Patient reported Outcome Variables to be assessed at different timepoints: 3*, 6 months, 1, 2, 5* year after index event or when occurs (*recommended, but not essential). With use of the following Scores: Surveys used: ODI - Oswestry Disability Index Version 2.1a: The ODI is free for all health care organizations, but a license is needed for use (therefore not included verbatimly in this version of the standard set). Please visit eprovide: https://eprovide.mapi-trust.org/ NPRS - Numerical Pain Rating Scale: The NPRS is free for all health care organizations, and a license is not needed. EQ-5D-3L - EuroQol‐5D descriptive system (EQ-­5D‐3L) and visual analogue scale (EQ-­VAS): The EQ-5D-3L is free for non-profits and academic research, but a license is needed for use (therefore not included verbatimly in this version of the standard set). https://euroqol.org/support/how-to-obtain-eq-5d/ Publication: R Carter Clement, Adina Welander, Caleb Stowell, Thomas D Cha, John L Chen, Michelle Davies, Jeremy C Fairbank, Kevin T Foley, Martin Gehrchen, Olle Hagg, Wilco C Jacobs, Richard Kahler, Safdar N Khan, Isador H Lieberman, Beth Morisson, Donna D Ohnmeiss, Wilco C Peul, Neal H Shonnard, Matthew W Smuck, Tore K Solberg, Bjorn H Stromqvist, Miranda L Van Hooff, Ajay D Wasan, Paul C Willems, William Yeo & Peter FRitzell (2015) A proposed set of metrics for standardized outcome reporting in the management of low back pain, Acta Orthopaedica, 86:5, 523-533 ICHOM was supported for the Low Back Pain Standard Set by Arthritis Research UK. For this version of the standard set, semantic annotation with UMLS CUIs has been added.

visit 2 & 3-4 Patient's Daily Diary starting dose of ropinirole Parkinson's Disease 101468/166

- 2017-09-04 - 1 Formulär, 2 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: administrative data, report of health related events
Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease

Patient's diary - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 2017-10-15 - 1 Formulär, 4 Item-grupper, 19 Dataelement, 1 Språk
Item-grupper: Patient's daily diary, Health related event, Study drug, Concomitant medication
Patient's diary - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Diary Cards for Dose 2 (Primary)

- 2019-01-10 - 1 Formulär, 18 Item-grupper, 79 Dataelement, 1 Språk
Item-grupper: Administrative data, Dose 2 - Local Symptoms - Vaccine 1, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 2 - Local Symptoms - Vaccine 2, Redness (Local Symptoms), Swelling (Local Symptoms), Pain (Local Symptoms), Dose 2 - Other Local Symptoms, Dose 2 - General Symptoms, Temperature (General Symptoms), Irritability / Fussiness (General Symptoms), Drowsiness (General Symptoms), Loss of Appetite (General Symptoms), Dose 2 - Other General Symptoms, Dose 2 - Medication, Reminder
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

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