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CDASH Concomitant Medication - Concomitant medication

- 20-06-18 - 1 Formulier, 2 Itemgroepen, 9 Data-elementen, 2 Talen
Itemgroepen: 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 Formulier, 10 Itemgroepen, 45 Data-elementen, 1 Taal
Itemgroepen: 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 Formulier, 10 Itemgroepen, 45 Data-elementen, 1 Taal
Itemgroepen: 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 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: 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 Formulier, 1 Itemgroep, 16 Data-elementen, 1 Taal
Itemgroep: 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

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

- 17-09-21 - 9 Formulieren, 2 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: 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 Itemgroepen 14 Data-elementen

STATUS OF TREATMENT BLIND

3 Itemgroepen 14 Data-elementen

Investigator INSTRUCTIONS

1 Itemgroep 1 Data-element

INVESTIGATIONAL PRODUCT

1 Itemgroep 8 Data-elementen

CONCOMITANT MEDICATIONS

1 Itemgroep 10 Data-elementen

Vital signs descirptions

1 Itemgroep 11 Data-elementen

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

- 20-07-20 - 1 Formulier, 3 Itemgroepen, 9 Data-elementen, 1 Taal
Itemgroepen: 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 Formulier, 7 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: 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.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Dosing Details

- 15-04-19 - 1 Formulier, 2 Itemgroepen, 8 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Dosing Details
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 Dosing Details form. It has to be filled in for all sessions each for day 1.

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

- 09-04-19 - 1 Formulier, 2 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Concomitant 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 concomitant medication form. It has to be filled in if the subject takes concomitant medication during the study trial. Please complete drug section for all drugs (including OTC)/ vaccines taken by mother within 3 months prior or during pregnancy.

GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188 - Study Medication and Compliance Record

- 06-11-17 - 1 Formulier, 2 Itemgroepen, 20 Data-elementen, 1 Taal
Itemgroepen: Study Medication And Compliance Record, Dose Reductions due to Adverse Experiences
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: Study Medication and Compliance Record

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