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Visit 10 GIMEMA CML0408 NCT00769327 - Visit 10

- 20/9/21 - 1 Formulier, 12 Itemgroepen, 122 Data-elementen, 2 Talen
Itemgroepen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), IMATINIB, Molecular Biology (peripheral blood), FISH (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 10 Form

Visit 16 GIMEMA CML0408 NCT00769327 - Visit 16

- 20/9/21 - 1 Formulier, 11 Itemgroepen, 117 Data-elementen, 2 Talen
Itemgroepen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), Molecular Biology (peripheral blood), FISH (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 16 Form

Visit 13 GIMEMA CML0408 NCT00769327 - Visit 13

- 20/9/21 - 1 Formulier, 5 Itemgroepen, 56 Data-elementen, 2 Talen
Itemgroepen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Molecular Biology (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 13 Form

Visit 5 GIMEMA CML0408 NCT00769327 - Visit 5

- 20/9/21 - 1 Formulier, 4 Itemgroepen, 44 Data-elementen, 2 Talen
Itemgroepen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 5 Form

Visit 7 GIMEMA CML0408 NCT00769327 - Visit 7

- 20/9/21 - 1 Formulier, 13 Itemgroepen, 127 Data-elementen, 2 Talen
Itemgroepen: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, NILOTINIB, FISH (from bone marrow blood), IMATINIB, Molecular Biology (peripheral blood), FISH (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 7 Form

Visit 3 GIMEMA CML0408 NCT00769327 - Visit 3

- 20/9/21 - 1 Formulier, 5 Itemgroepen, 49 Data-elementen, 2 Talen
Itemgroepen: Physical Examination, Complete Blood Count, NILOTINIB, Biochemistry, Electrocardiogram
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 3 Form

Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Cycle 1 - Week 4

- 13/10/20 - 1 Formulier, 9 Itemgroepen, 163 Data-elementen, 1 Taal
Itemgroepen: Date of visit, Assessment Date, Neurologic Examination, Neurologic Symptoms, Associated with, Neoplasms, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Vital signs, Continuation status, Study
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

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Treatment Period Day -1 - Physical Examination

- 4/3/19 - 1 Formulier, 2 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Physical Examination
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Treatment Period Day 14 - Physical Examination

- 4/3/19 - 1 Formulier, 2 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Physical Examination
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Screening Visit - Vital Signs

- 4/3/19 - 1 Formulier, 2 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Vital Signs
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Screening Visit - Physical Examination

- 4/3/19 - 1 Formulier, 2 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Physical Examination
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Treatment Period day -1 - 12-lead ECG (Semi-Supine)

- 14/1/19 - 1 Formulier, 1 Itemgroep, 8 Data-elementen, 1 Taal
Itemgroep: 12-lead ECG
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

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