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Table des matières
  1. 1. Essai clinique
  2. 2. Routinedokumentation
  3. 3. Études de registres/cohortes
  4. 4. Assurance qualité
  5. 5. Standard de données
  6. 6. Questionnaire pour les patients
  7. 7. Spécialité médicale
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Persönliches Interview SHIP-Trend-1 Frauenfragen

- 14/02/2021 - 1 Formulaire, 1 Groupe Item, 89 Eléments de données, 1 Langue
Groupe Item: Frauenfragen
Frauenfragen form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name TREND.TREND1.INT.FRAU.FRAU. 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

MRT SHIP-Trend-0 MRT-findings: gynaecological organs

- 08/12/2017 - 1 Formulaire, 1 Groupe Item, 15 Eléments de données, 2 Langues
Groupe Item: MRT-findings: gynaecological organs
MRT-findings: gynaecological organs form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.MRT.MRTBEF.MRTGYN. 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

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Follow-Up

- 20/11/2019 - 1 Formulaire, 9 Groupes Item, 29 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Follow-up, Month, Clinical Trials, Result, X-Ray Computed Tomography, Tumor Markers, follow-up visit date, Response to treatment, Evaluation, Therapeutic procedure, Other, Investigator Signature
Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Status of Treatment Blind

- 29/08/2019 - 1 Formulaire, 1 Groupe Item, 4 Eléments de données, 1 Langue
Groupe Item: Blinded Clinical Study, Status
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female 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: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

FOLLOW-UP SURVIVAL WORKSHEET Roche H0650g Breast Cancer - FOLLOW-UP SURVIVAL WORKSHEET

- 20/05/2017 - 1 Formulaire, 1 Groupe Item, 8 Eléments de données, 1 Langue
Groupe Item: follow up
Study part: Follow-up survival worksheet. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

PATIENT DEATH REPORT Roche H0650g Breast Cancer - PATIENT DEATH REPORT

- 20/05/2017 - 1 Formulaire, 1 Groupe Item, 12 Eléments de données, 1 Langue
Groupe Item: death report
Study part: Patient death report. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

FOLLOW-UP SURVIVAL FORM Roche H0650g Breast Cancer - FOLLOW-UP SURVIVAL FORM

- 20/05/2017 - 1 Formulaire, 1 Groupe Item, 5 Eléments de données, 1 Langue
Groupe Item: FOLLOW-UP
Study part: Follow-up survival form. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Follow-up

- 25/06/2020 - 1 Formulaire, 10 Groupes Item, 187 Eléments de données, 1 Langue
Groupes Item: Date of visit, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Experimental drug, Continuation status, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Conclusion, Clinical Research, Cessation of life, Pregnancy, Information
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer 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: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Survival Follow-Up

- 13/10/2020 - 1 Formulaire, 2 Groupes Item, 5 Eléments de données, 1 Langue
Groupes Item: Date of visit, Assessment Date, follow-up, Continuance of life
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

DAY 0 EORTC Roche H0650g Breast Cancer - DAY 0 EORTC

- 28/05/2017 - 1 Formulaire, 1 Groupe Item, 3 Eléments de données, 1 Langue
Groupe Item: EORTC
Study part: Day 0 EORTC. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

TREATMENT DISCONTINUATION REPORT Roche H0650g Breast Cancer - TREATMENT DISCONTINUATION REPORT

- 22/05/2017 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Therapy discontinuation
Study part: Treatment discontinuation report. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "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"

On-Study - Recurrent Gynecologic Cancer - On-study Form - 2019342v2.31 - Recurrent Gynecologic Cancer - On-study Form

- 08/01/2015 - 1 Formulaire, 6 Groupes Item, 50 Eléments de données, 1 Langue
Groupes Item: CRF Header, GYN: FORM ADMINISTRATION, GYN: DISEASE DESCRIPTION - PRIOR HISTORY, GYN: DISEASE DESCRIPTION - CURRENT HISTORY, GYN: PRIOR TREATMENT FOR GYNECOLOGIC CANCER, Comments
Recurrent Gynecologic Cancer - On-study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99CD59C5-A974-3FA4-E034-080020C9C0E0

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