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Perseived deficits questionnaire CRFs Multiple Sklerosis Tysabri NCT00027300

- 30-01-17 - 2 Formulieren, 1 Itemgroep, 20 Data-elementen, 1 Taal
Itemgroep: Perceived deficits questionnaire
The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS. Documentation process: This form ist to be obtained in week 24, week 52, week 104, week, 120, week, 128 and Premature Study Withdrawl.

F.2

0 Itemgroep 0 Data-element

Johns Hopkins RLS QOL Questionnaire (RLSQOL) Ropinirole Restless Legs Syndrom NCT00355641 - Johns Hopkins RLS QOL Questionnaire

- 05-08-17 - 1 Formulier, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: Assessment of quality of life
Study part: Johns Hopkins RLS QOL Questionnaire. A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. Phase: phase 3. 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. Study ID: 101468/206. Clinical Study ID: 101468/206.

Drug Safety Patient-Reported Adverse Drug Event Questionnaire Part A

- 20-09-21 - 1 Formulier, 19 Itemgroepen, 306 Data-elementen, 1 Taal
Itemgroepen: General Information, Drug use, Symptoms, Symptoms Eyes eyelids, Symptoms Ear, nose and throat swallowing, Symptoms Sweating blushing temperature flu, Symptoms Mouth lips speech, Symptoms Tongue teeth taste, Symptoms chest sleep apnea blood, Symptoms Bladder urination, Symptoms Intestines stomach vomiting, Symptoms Skin hair nails, Symptoms Genitals menopause menstruation, Symptoms Muscles bones joints, Symptoms Dizziness falling balance, Symptoms Head brain moods, Symptoms Sleep fatigue, Symptoms Eating drinking weight, Symptoms Infection edema fungal infection
Study description: Patient-Reported Adverse Drug Event Questionnaire for the evaluation of drug safety, Part A. Publication granted by Sieta de Vries. Publishing results based on the questionnaire should include the following reference: de Vries, S.T., Mol, P.G.M., de Zeeuw, D. et al. Drug Saf (2013) 36: 765. doi:10.1007/s40264-013-0036-8

VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

- 27-07-17 - 1 Formulier, 2 Itemgroepen, 39 Data-elementen, 2 Talen
Itemgroepen: Patient administration, VISUAL FUNCTIONING QUESTIONNAIRE - 25 (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

VISUAL FUNCTIONING QUESTIONNAIRE - 25 (DAY 0) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

- 27-07-17 - 1 Formulier, 2 Itemgroepen, 39 Data-elementen, 2 Talen
Itemgroepen: Patient administration, VISUAL FUNCTIONING QUESTIONNAIRE - 25 (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

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