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On-Study - PHYSICAL EXAM - 2407645v1.0 - PHYSICAL EXAM

- 20.09.21 - 1 Formular, 2 Itemgruppen, 8 Datenelemente, 1 Sprache

Itemgruppen: PHYSICAL EXAM, COMMENTS

Physical Exam form for C3D 3.12 Adopters Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=01603C3C-DD2D-4BA2-E044-0003BA3F9857

On-Study - PHYSICAL EXAM SCREEN - 2390964v1.0 - PHYSICAL EXAM SCREEN

- 20.09.21 - 1 Formular, 2 Itemgruppen, 6 Datenelemente, 1 Sprache

Itemgruppen: PHYSICAL EXAM--SCREENING, COMMENTS

Physical Exam Screening form for C3D 3.12 Adopters Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FEF2E3DC-3E2D-329B-E034-0003BA3F9857

On-Study - Physical Exam (continued) - 2803398v1.0 - Physical Exam (continued)

- 09.01.15 - 1 Formular, 3 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: DCP Template Header, Baseline Medical/Surgical History (continued), DCP Template Footer

The Division of Cancer Prevention's physical exam (continued) case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C120DDA-54D8-39FD-E044-0003BA3F9857

Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933 - Physical Examination

- 10.06.20 - 1 Formular, 2 Itemgruppen, 31 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Physical Examination

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Physical Examination Form is used to record the physical examination at screening visit.

Premature Study Withdrawal Visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 19.02.22 - 1 Formular, 10 Itemgruppen, 33 Datenelemente, 1 Sprache

Itemgruppen: Subject Identification, Vital Signs, Physical examination, EDSS, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Premature Study Withdrawal Visit

Physical Exam Cardiovascular Health Study (CHS)

- 19.07.16 - 1 Formular, 6 Itemgruppen, 42 Datenelemente, 1 Sprache

Itemgruppen: Measured Walk, Grip Strength, General Physical Examination, Chair stands, Other physical findings/comments, Date of interview

Documentation part: Record 17 Physical Exam The Cardiovascular Health Study (CHS) was initiated by the National Heart, Lung and Blood Institute (NHLBI) in 1987 to determine the risk factors for development and progression of cardiovascular disease (CVD) in older adults, with an emphasis on subclinical measures. The study recruited 5,888 adults aged 65 or older at entry in four U.S. communities and conducted extensive annual clinical exams between 1989-1999 along with semi-annual phone calls, events adjudication, and subsequent data analyses and publications. Additional data were collected by studies ancillary to CHS. With the exception of annual clinic visits, these activities are still ongoing. Data obtained from: https://chs-nhlbi.org/ Permission granted by: Erika Enright.

Present aftercare Physician’s questionnaire for aftercare ABC study - Present aftercare Physician’s questionnaire for aftercare

- 20.09.21 - 1 Formular, 11 Itemgruppen, 99 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Medical Examination, Medical consultation, laboratory tests, Aftercare, medical consultation early cancer prevention, vaccination status, cardiovascular risk factor, Rehabilitation measures, Physical therapy, Medication

Study part: Present aftercare Physician’s questionnaire for aftercare ABC Study. Aftercare pattern in adult patients with blood cancer and blood cancer early stage: Impact on health related endpoints, quality of life and health resource use. University clinic essen, (Klinik für Hämatologie Uniklinik Essen, UKE), department hematology. Permission granted by Claudia Ose.

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - Significant medical/surgical history, physical examination and medication

- 23.02.18 - 1 Formular, 6 Itemgruppen, 18 Datenelemente, 1 Sprache

Itemgruppen: Medical/Surgical condition, Medical/Surgical condition, Prior and concomitant medication, Prior and concomitant medication, RLS Pharmacotherapy history, RLS Pharmacotherapy history

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - RLS Demographics and Examination Procedure

- 20.02.18 - 1 Formular, 6 Itemgruppen, 18 Datenelemente, 1 Sprache

Itemgruppen: Demography, Vital signs, Orthostatic vital signs, Electrocardiogram (12 lead), Laboratory evaluation, Pregnancy Dipstick

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

Dyskinesias GSK study Dyskinesia in Parkinson's disease NCT00363727

- 08.09.17 - 1 Formular, 2 Itemgruppen, 7 Datenelemente, 1 Sprache

Itemgruppen: General information, Dyskinesia

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Dyskinesias.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Diagnosis criteria Amyotrophic lateral sclerosis (ALS) (Diagnosekriterien Amyotrophe Lateralsklerose (ALS))

- 20.09.21 - 1 Formular, 12 Itemgruppen, 34 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Amyotrophic lateral sclerosis (ALS), Diagnostic criteria and motor subtypes, classical ALS, ALS exclusion criteria, Diagnosis facilitation, ALS occurrence, ALS (not impaired) without cognitive impairment, ALS (cognitive impaired), ALS (behaviourally impaired), ALS (cognitively and behaviourally impaired), ALS‐FTD, ALS (without cognitive impairment, genetic risk for FTD)

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Diagnosis criteria Amyotrophic lateral sclerosis (ALS) form. It has to be filled in if an ALS is diagnosed. Note: If there is a motor neuron disease, fill in the motor neuron disease assessment!

Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181 - Study Period

- 11.12.18 - 1 Formular, 17 Itemgruppen, 85 Datenelemente, 1 Sprache

Itemgruppen: Drug Screen, Ethanol Measurement, Physical Examination, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Laboratory Procedures, Urinalysis, Pharmacokinetic aspects, Blood, Vital signs, 12-Lead-ECG, 12 lead ECG, Abnormality, Randomization, Numbers, Experimental drug, Therapeutic procedure, Confirmation, Pharmacokinetic aspects, Blood, Pharmacokinetic aspects, Blood, Metabolite, Pharmacokinetic aspects, Urine, Pharmacokinetic aspects, Faeces, Entero string test

Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

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