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DIAGNOSIS Roche H0650g Breast Cancer - DIAGNOSIS

- 5/29/17 - 1 form, 3 itemgroups, 45 items, 1 language
Itemgroups: PRIMARY DIAGNOSIS, Diagnosis Metastasis, method of assessment
Study part: Diagnosis. 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"

UNSCHEDULED TUMOR ASSESSMENT Roche H0650g Breast Cancer - UNSCHEDULED TUMOR ASSESSMENT

- 5/29/17 - 1 form, 1 itemgroup, 23 items, 1 language
Itemgroup: Tumor assessment
Study part: Unscheduled Tumor Assessment. 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"

RADIOTHERAPY TREATMENT WHILE ON STUDY Roche H0650g Breast Cancer - RADIOTHERAPY TREATMENT WHILE ON STUDY

- 3/15/21 - 1 form, 1 itemgroup, 8 items, 1 language
Itemgroup: RADIOTHERAPY
Study part: Radiotherapy treatment while on study. 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"

STUDY TERMINATION TUMOR ASSESSMENT Roche H0650g Breast Cancer - STUDY TERMINATION TUMOR ASSESSMENT

- 5/29/17 - 1 form, 1 itemgroup, 23 items, 1 language
Itemgroup: Tumor assessment
Study part: Study Termination Tumor Assessment. 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"

4 WEEK CONFIRMATION OF RESPONSE WORKSHEET Roche H0650g Breast Cancer - 4 WEEK CONFIRMATION OF RESPONSE WORKSHEET

- 5/29/17 - 1 form, 1 itemgroup, 23 items, 1 language
Itemgroup: Tumor assessment
Study part: 4 Week Confirmation of Response 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"

TUMOR ASSESSMENT WORKSHEET & TUMOR ASSESSMENT Roche H0650g Breast Cancer - TUMOR ASSESSMENT WORKSHEET & TUMOR ASSESSMENT

- 5/29/17 - 1 form, 4 itemgroups, 39 items, 1 language
Itemgroups: tumor location, Tumor assessment, tumor location, worksheet tumor assessment
Study part: Tumor Assessment Worksheet & Tumor Assessment. 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"

CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - CHEST X-RAY (AP AND LATERAL)

- 5/16/17 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: Chest X-Ray
Study part: Chest X- ray. 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"

STUDY TERMINATION CHEST X-RAY (AP AND LATERAL) Roche H0650g Breast Cancer - STUDY TERMINATION CHEST X-RAY (AP AND LATERAL)

- 5/20/17 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: Chest X-Ray
Study part: Study Termination Chest X- ray. 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 Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Liver imaging

- 1/26/21 - 1 form, 11 itemgroups, 60 items, 1 language
Itemgroups: Date of hepatic or liver imaging test, method used for imaging test, images technically adequate, liver size, liver texture, diffuse and/or geographic fatty infiltrate of the liver, Ascites present, Focal Hepatic Lesions characterisable, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities
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 documents any liver imaging, if taken during the study.

Tuko SenPraeBiopsie MS Sub University Hospital Muenster (UKM) Subform

- 11/13/16 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: Multidisciplinary Care Conference
Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: Tuko SenPraeBiopsie MS Sub

Birth sheet, ultrasound diagnostics Routine documentation in German hospitals DMI

- 9/20/21 - 1 form, 2 itemgroups, 30 items, 2 languages
Itemgroups: Ultrasound examination, Ultrasound examination
Routine documentation in German hospitals. Source file name: SD070109_Geburtenbogen. Examplary forms provided by DMI (http://www.dmi.de/)

Birth sheet, fetal Doppler sonography Routine documentation in German hospitals DMI

- 7/30/17 - 1 form, 5 itemgroups, 16 items, 2 languages
Itemgroups: A. umbilicalis, A. cerebri media, A. uterina right, A. uterina left, Findings
Routine documentation in German hospitals. Source file name: SD070109_Geburtenbogen. Examplary forms provided by DMI (http://www.dmi.de/)

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