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CDASH Concomitant Medication - Concomitant medication

- 20.06.18 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 2 Sprachen

Itemgruppen: General information, Details

translated and modified from CDASH 2011-10-24 http://www.cdisc.org

Visit 9 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 19.02.22 - 1 Formular, 10 Itemgruppen, 45 Datenelemente, 1 Sprache

Itemgruppen: Date of Visit, Physical Examination, Orthostatic vital signs, 12 Lead ECG, Weight, Waist and Hip Circumference, Pregnancy Test, EQ-5D, ADDQol, Diab-MedSat

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Visit 9

Early Discontinuation Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 18.02.22 - 1 Formular, 10 Itemgruppen, 45 Datenelemente, 1 Sprache

Itemgruppen: Date of Visit, Physical Examination, Orthostatic vital signs, 12 Lead ECG 1, Weight, Waist and Hip Circumference, Pregnancy Test, EQ-5D, ADDQol, Diab-MedSat

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Early Discontinuation

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Prior Medication

- 20.09.21 - 1 Formular, 2 Itemgruppen, 12 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Prior Medication

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the prior medication form. It has to be filled in for screening.

Treatment - Study Medication Administration - 3280117v1.0 - Study Medication Administration

- 20.09.21 - 1 Formular, 1 Itemgruppe, 16 Datenelemente, 1 Sprache

Itemgruppe: Study Medication Administration

Record study medication administration. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD24494B-49FC-235C-E040-BB89AD4305F5

EUROASPIRE III- Coronary heart disease Medication Patient Interview - Medication Patient Interview

- 17.09.21 - 1 Formular, 2 Itemgruppen, 96 Datenelemente, 1 Sprache

Itemgruppen: Demographic Information, Medication

Provided by Prof. Keil Source: Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Keil U; EUROASPIRE Study Group. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009 Mar 14;373(9667):929-40. doi: 10.1016/S0140-6736(09)60330-5. PubMed PMID: 19286092

EUROASPIRE III- Coronary heart disease Medication at discharge - Medication at discharge

- 17.09.21 - 1 Formular, 2 Itemgruppen, 97 Datenelemente, 1 Sprache

Itemgruppen: Demographic Information, Medication

Provided by Prof. Keil Source: Kotseva K, Wood D, De Backer G, De Bacquer D, Pyörälä K, Keil U; EUROASPIRE Study Group. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009 Mar 14;373(9667):929-40. doi: 10.1016/S0140-6736(09)60330-5. PubMed PMID: 19286092

Ropinirole Case Report Form GSK RRL100013 - NON-SERIOUS ADVERSE EVENT

- 17.09.21 - 9 Formulare, 2 Itemgruppen, 13 Datenelemente, 1 Sprache

Itemgruppen: NON-SERIOUS ADVERSE EVENT, NON-SERIOUS ADVERSE EVENTS

Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Ropinirole Case Report Form GSK RRL100013

3 Itemgruppen 14 Datenelemente

STATUS OF TREATMENT BLIND

3 Itemgruppen 14 Datenelemente

Investigator INSTRUCTIONS

1 Itemgruppe 1 Datenelement

INVESTIGATIONAL PRODUCT

1 Itemgruppe 8 Datenelemente

CONCOMITANT MEDICATIONS

1 Itemgruppe 10 Datenelemente

Vital signs descirptions

1 Itemgruppe 11 Datenelemente

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Persönliches Interview SHIP-Trend-1 Medikamentenanamnese

- 19.02.21 - 1 Formular, 1 Itemgruppe, 60 Datenelemente, 1 Sprache

Itemgruppe: Medikamentenanamnese

Medikamentenanamnese form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.INT.MEDIK.MEDIK. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Lapatinib

- 20.07.20 - 1 Formular, 3 Itemgruppen, 9 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Lapatinib Dosing, Treatment confirmation

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the Lapatinib Dosing information. It has to be filled in once for each week 1, week 2 and week 3.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Lapatinib diary

- 04.07.20 - 1 Formular, 7 Itemgruppen, 10 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Week number and study day, Predose Overnight Fast, Lapatinib Dosage, Count of entities, Postdose Fasting, Post-dose Vomiting, Therapeutic procedure, Confirmation

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the Lapatinib diary. This form is for dosing and meal data from the diary only. Go to visits Week 1 to Week 3 for Lapatinib and Meal data from clinic visits. This form has to be filled in for each week and each study day of the trial.

FHIR v4.0.1 - Resource Medication (3)

- 09.03.20 - 1 Formular, 1 Itemgruppe, 5 Datenelemente, 1 Sprache

Itemgruppe: Medication

This form contains an incomplete implementation of the FHIR Resource Medication, v4.0.1 . After preliminary review, it contains the data elements that request clinical information. https://www.hl7.org/fhir/resourcelist.html (accessed at 28.11.2019)

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