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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Study Treatment Administration; Tumor Assessment; Site evaluation for non-target lesion(s) and new lesions; Target lesion(s) evaluation; Response Assessment (Report Final and Annex Report 2 Final)

- 29-10-20 - 1 Formulier, 9 Itemgroepen, 58 Data-elementen, 1 Taal
Itemgroepen: Administrative, Study Treatment Administration (Visit 1), Study Treatment Administration (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 27) , Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up), Tumor Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up) , Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up), Site evaluation for non-target lesion(s) and new lesions (Visit 7, 11, 14 ,19, 21, 23 - 28, Follow-up), Target lesion(s) evaluation (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up), Response Assessment (Visit 7, 11, 14, 19, 21, 23 - 28, Follow-up)
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Laboratory Tests (Annex Report 2 Final)

- 28-10-20 - 1 Formulier, 8 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Administrative, Laboratory Tests, Laboratory Assay, Haematology, Biochemistry, Hepatic Function, Renal Function, HCG Urine or Blood Pregnancy Test
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Tumor Assessment; Baseline Melanoma Evaluation (Annex Report 2 Final)

- 28-10-20 - 1 Formulier, 7 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Administrative, Tumor Assessment, Tumor Assessment , Baseline Melanoma Evaluation, Site and non-target lesions baseline evaluation, Target lesion(s) baseline evaluation, Target lesions
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Informed Consent; Optional Translational Research and other Research; Demographics; Cutaneous Melanoma: Disease chracteristics (Annex Report 2 Final)

- 27-10-20 - 1 Formulier, 5 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Administrative, Informed Consent, Optional Translational Research and other Research, Demographics, Cutaneous Melanoma: Disease chracteristics
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - Coeliac Disease; Antiphospholipid Syndrome; Autoimmune Haemolytic Anaemia

- 07-10-20 - 1 Formulier, 25 Itemgroepen, 85 Data-elementen, 1 Taal
Itemgroepen: Administrative, Coeliac disease, Coeliac disease - Signs and Symptoms, Coeliac disease - Other signs and symptoms, Coeliac disease - Other signs and symptoms , Coeliac disease - Diagnostic Test Results, Coeliac disease - Other Diagnostic Test Results , Coeliac disease - Other Diagnostic Test Results , Coeliac disease - Other diagnostic Procedure, Antiphospholipid Syndrome, Antiphospholipid Syndrome - Signs and symptoms (supporting the final diagnosis), Antiphospholipid Syndrome - Other Signs and symptoms, Antiphospholipid Syndrome - Other Signs and symptoms , Antiphospholipid Syndrome - Diagnostic Test Results, Antiphospholipid Syndrome - Other Diagnostic Test Results , Antiphospholipid Syndrome - Other Diagnostic Test Results , Antiphospholipid Syndrome - Other diagnostic Procedure , Autoimmune Haemolytic Anaemia, Autoimmune Haemolytic Anaemia - Signs and symptoms (supporting the final diagnosis), Autoimmune Haemolytic Anaemia - Other Signs and symptoms , Autoimmune Haemolytic Anaemia - Other Signs and symptoms , Autoimmune Haemolytic Anaemia - Diagnostic Test Results , Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results , Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results , Autoimmune Haemolytic Anaemia - Other diagnostic Procedure
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Unscheduled Visit

- 16-09-20 - 1 Formulier, 14 Itemgroepen, 39 Data-elementen, 1 Taal
Itemgroepen: Administrative, Unscheduled Visit , Physical Examination (Unscheduled Visit), Weight (Unscheduled Visit) , Conclusion of unscheduled visit , Unscheduled Tumor Assessment, Tumor Assessment, Tumor Assessment , Site evaluation for non-target lesion(s) and new lesions, Site evaluation for non-target lesion(s) and new lesions, Target lesion(s) evaluation, Response Assessment, Laboratory Tests, Laboratory Tests
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Laboratory Tests

- 25-08-20 - 1 Formulier, 8 Itemgroepen, 16 Data-elementen, 1 Taal
Itemgroepen: Administrative, Laboratory Tests, Laboratory Assay, Haematology, Biochemistry, Hepatic Function, Renal Function, HCG Urine or Blood Pregnancy Test
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Tumor Assessment; Baseline Melanoma Evaluation

- 21-08-20 - 1 Formulier, 7 Itemgroepen, 18 Data-elementen, 1 Taal
Itemgroepen: Administrative, Tumor Assessment, Tumor Assessment , Baseline Melanoma Evaluation, Site and non-target lesions baseline evaluation, Target lesion(s) baseline evaluation, Target lesions
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Informed Consent; Optional Translational Research and other Research; Demographics; Cutaneous Melanoma: Disease chracteristics

- 18-08-20 - 1 Formulier, 5 Itemgroepen, 17 Data-elementen, 1 Taal
Itemgroepen: Administrative, Informed Consent, Optional Translational Research and other Research, Demographics, Cutaneous Melanoma: Disease chracteristics
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

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