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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Physical Exam Cancer Prevention

- 7/30/15 - 1 form, 3 itemgroups, 29 items, 1 language
Itemgroups: Header, Physical Exam, DCP Template Footer
On-Study - Physical Exam - 2803173v1.0 The Division of Cancer Prevention's physical exam case report form (CRF) template. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5C0F9C5A-FB66-15A0-E044-0003BA3F9857

Oral GW786034 treatment for ovarian cancer NCT00281632 - Screening

- 3/15/21 - 1 form, 24 itemgroups, 129 items, 2 languages
Itemgroups: Header, Eligibility Question, Demography, Physical examination, Disease Characteristics, Metastatic Disease Site, local laboratory, Residual toxicities related to previous therapy for cancer, Residual toxicities, Cancer related current medical conditions, Medical Conditions, non-cancer related medical conditions, Medical Conditions, Prior anti-cancer therapy, Prior anti-cancer therapy - medication, Prior anti-cancer therapy - radiotherapy, Vital signs, ECOG Performance Status Scale, 12 LEAD ECG, 12-lead ECG Abnormalities, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Electronically transferred laboratory data
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Oral GW786034 treatment for ovarian cancer NCT00281632 - Post-Treatment Assessments

- 5/16/18 - 1 form, 12 itemgroups, 54 items, 1 language
Itemgroups: Header, Vital signs, ECOG Performance Status Scale, Electronically transferred laboratory data, Physical examination, serum pregnancy test, CONCOMITANT MEDICATIONS, ADVERSE EVENTS, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, 12 LEAD ECG
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

CLINICAL ASSESSMENT Roche H0650g Breast Cancer - CLINICAL ASSESSMENT

- 5/16/17 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: CLINICAL ASSESSMENT
Study part: Clinical 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"

BASELINE PHYSICAL EXAMINATION Roche H0650g Breast Cancer - BASELINE PHYSICAL EXAMINATION

- 5/17/17 - 1 form, 1 itemgroup, 37 items, 1 language
Itemgroup: PHYSICAL EXAMINATION
Study part: Baseline physical examination. 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"

12-LEAD ELECTROCARDIOGRAM Roche H0650g Breast Cancer - 12-LEAD ELECTROCARDIOGRAM

- 5/16/17 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: 12-LEAD ELECTROCARDIOGRAM
Study part: 12- Lead electrocardiogram. 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"

PULMONARY FUNCTION TEST Roche H0650g Breast Cancer - PULMONARY FUNCTION TEST

- 5/16/17 - 1 form, 1 itemgroup, 3 items, 1 language
Itemgroup: PULMONARY FUNCTION TEST
Study part: Pulmonary function test. 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 CLINICAL ASSESSMENT Roche H0650g Breast Cancer - STUDY TERMINATION CLINICAL ASSESSMENT

- 5/20/17 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: CLINICAL ASSESSMENT
Study part: Study termination clinical 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"

STUDY TERMINATION PHYSICAL EXAMINATION Roche H0650g Breast Cancer - STUDY TERMINATION PHYSICAL EXAMINATION

- 5/20/17 - 1 form, 1 itemgroup, 47 items, 1 language
Itemgroup: PHYSICAL EXAMINATION
Study part: Study termination physical examination. 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"

WEEK 96 PHYSICAL EXAMINATION Roche H0650g Breast Cancer - WEEK 96 PHYSICAL EXAMINATION

- 5/17/17 - 1 form, 1 itemgroup, 39 items, 1 language
Itemgroup: PHYSICAL EXAMINATION
Study part: Week 96 physical examination. 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"

WEEK 2 (DAY 7) INFUSION Roche H0650g Breast Cancer - WEEK 2 (DAY 7) INFUSION

- 5/21/17 - 1 form, 3 itemgroups, 48 items, 1 language
Itemgroups: Infusion, INFUSION, Vital Signs
Study part: Week 2 (Day 7) Infusion. 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"

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Screening - Significant Medical/ Surgical History and Physical Examination; History of Ovarian Cancer; Tumor Marker

- 8/23/19 - 1 form, 6 itemgroups, 18 items, 1 language
Itemgroups: Administrative, Significant Medical/ Surgical History and Physical Examination, Significant Medical/ Surgical History and Physical Examination , History of Ovarian Cancer, Metastatic, Tumor Marker (CA-125) (7 days prior to Day 1)
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

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