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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - Rheumatic Diseases; Systemic Lupus Erythematosus or Cutaneous Lupus; Sjogren's Syndrome (Report Final and Annex Report 2 Final)

- 02.11.20 - 1 Formulier, 25 Itemgroepen, 95 Data-elementen, 1 Taal
Itemgroepen: Administrative, Rheumatic Diseases, Rheumatic Diseases - Signs and Symptoms, Rheumatic diseases - Other signs and symptoms, Rheumatic diseases - Other signs and symptoms , Rheumatic diseases - Diagnostic Test Results, Rheumatic diseases - Other Diagnostic Test Results , Rheumatic diseases - Other Diagnostic Test Results , Rheumatic diseases - Other diagnostic Procedure, Systemic Lupus Erythematosus or Cutaneous Lupus, Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms (supporting the final diagnosis), Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms, Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms , Systemic Lupus Erythematosus or Cutaneous Lupus - Diagnostic Test Results, Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results , Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results , Systemic Lupus Erythematosus or Cutaneous Lupus - Other diagnostic Procedure , Sjogren's Syndrome, Sjogren's Syndrome - Signs and symptoms (supporting the final diagnosis), Sjogren's Syndrome - Other Signs and symptoms , Sjogren's Syndrome - Other Signs and symptoms , Sjogren's Syndrome - Diagnostic Test Results , Sjogren's Syndrome - Other Diagnostic Test Results , Sjogren's Syndrome - Other Diagnostic Test Results , Sjogren's Syndrome - 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 - Eligibility Check

- 17.09.21 - 1 Formulier, 4 Itemgroepen, 29 Data-elementen, 1 Taal
Itemgroepen: Administrative, Eligibility Check, Inclusion Criteria, Exclusion Criteria
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 - Eligibility Check (Annex Report 2 Final)

- 17.09.21 - 1 Formulier, 4 Itemgroepen, 29 Data-elementen, 1 Taal
Itemgroepen: Administrative, Eligibility Check, Inclusion Criteria, Exclusion Criteria
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 - Laboratory Reference Ranges, Use of Human Samples by GSK, Investigator's Signature (Report Final and Annex Report 2 Final)

- 03.11.20 - 1 Formulier, 8 Itemgroepen, 31 Data-elementen, 1 Taal
Itemgroepen: Administrative, Laboratory Reference Ranges, Laboratory Reference Ranges - Haematology, Laboratory Reference Ranges - Biochemistry, Laboratory Reference Ranges - Hepatic Function, Laboratory Reference Ranges - Renal Function , Use of human samples by GSK, Investigator's Signature
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 - Other relevant information, Investigator signature (Report Final and Annex Report 2 Final)

- 03.11.20 - 1 Formulier, 3 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Administrative, Other relevant information (including evolution), Investigator Signature
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 - Autoimmune Liver Diseases; Sarcoidosis; Other diseases (Report Final and Annex Report 2 Final)

- 03.11.20 - 1 Formulier, 23 Itemgroepen, 85 Data-elementen, 1 Taal
Itemgroepen: Administrative, Autoimmune Liver Diseases, Autoimmune Liver Diseases - Signs and Symptoms, Autoimmune Liver Diseases - Other signs and symptoms, Autoimmune Liver Diseases - Other signs and symptoms , Autoimmune Liver Diseases - Diagnostic Test Results, Autoimmune Liver Diseases - Other Diagnostic Test Results , Autoimmune Liver Diseases - Other Diagnostic Test Results , Autoimmune Liver Diseases - Other diagnostic Procedure, Sarcoidosis, Sarcoidosis - Signs and symptoms, Sarcoidosis - Other Signs and symptoms, Sarcoidosis - Other Signs and symptoms , Sarcoidosis - Diagnostic Test Results, Sarcoidosis - Other Diagnostic Test Results , Sarcoidosis - Other Diagnostic Test Results , Sarcoidosis - Other diagnostic Procedure , Other disease, Other disease - Signs and symptoms, Other disease - Diagnostic Test Results , Other disease - Other Diagnostic Test Results , Other disease - Other Diagnostic Test Results , Other disease - 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 - IMD Report - (Glomerulo)Nephritis; Inflammatory Skin Diseases; Autoimmune Myocarditis (Report Final and Annex Report 2 Final)

- 03.11.20 - 1 Formulier, 26 Itemgroepen, 97 Data-elementen, 1 Taal
Itemgroepen: Administrative, (Glomerulo)Nephritis, (Glomerulo)Nephritis - Signs and Symptoms, (Glomerulo)Nephritis - Other signs and symptoms, (Glomerulo)Nephritis - Other signs and symptoms , (Glomerulo)Nephritis - Diagnostic Test Results, (Glomerulo)Nephritis - Other Diagnostic Test Results , (Glomerulo)Nephritis - Other Diagnostic Test Results , (Glomerulo)Nephritis - Other diagnostic Procedure, Inflammatory skin diseases, Inflammatory skin diseases - Signs and symptoms, Inflammatory skin diseases - Signs and symptoms (skin lesions), Inflammatory skin diseases - Other Signs and symptoms, Inflammatory skin diseases - Other Signs and symptoms , Inflammatory skin diseases - Diagnostic Test Results, Inflammatory skin diseases - Other Diagnostic Test Results , Inflammatory skin diseases - Other Diagnostic Test Results , Inflammatory skin diseases - Other diagnostic Procedure , Autoimmune Myocarditis, Autoimmune Myocarditis - Signs and symptoms, Autoimmune Myocarditis - Other Signs and symptoms , Autoimmune Myocarditis - Other Signs and symptoms , Autoimmune Myocarditis - Diagnostic Test Results , Autoimmune Myocarditis - Other Diagnostic Test Results , Autoimmune Myocarditis - Other Diagnostic Test Results , Autoimmune Myocarditis - 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 - IMD Report - Coeliac Disease; Antiphospholipid Syndrome; Autoimmune Haemolytic Anaemia (Report Final and Annex Report 2 Final)

- 03.11.20 - 1 Formulier, 25 Itemgroepen, 87 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 - IMD Report - Autoimmune thyroid diseases; Addisons's disease; Inflammatory bowel diseases (Report Final and Annex Report 2 Final)

- 02.11.20 - 1 Formulier, 25 Itemgroepen, 93 Data-elementen, 1 Taal
Itemgroepen: Administrative, Autoimmune thyroid diseases, Autoimmune thyroid diseases - Signs and Symptoms, Autoimmune thyroid diseases - Other signs and symptoms, Autoimmune thyroid diseases - Other signs and symptoms , Autoimmune thyroid diseases - Diagnostic Test Results, Autoimmune thyroid diseases - Other Diagnostic Test Results , Autoimmune thyroid diseases - Other Diagnostic Test Results , Autoimmune thyroid diseases - Other diagnostic Procedure, Addison's disease, Addison's disease - Signs and symptoms (supporting the final diagnosis), Addison's disease - Other Signs and symptoms, Addison's disease - Other Signs and symptoms , Addison's disease - Diagnostic Test Results, Addison's disease - Other Diagnostic Test Results , Addison's disease - Other Diagnostic Test Results , Addison's disease - Other diagnostic Procedure , Inflammatory bowel diseases, Inflammatory bowel diseases - Signs and symptoms (supporting the final diagnosis), Inflammatory bowel diseases - Other Signs and symptoms , Inflammatory bowel diseases - Other Signs and symptoms , Inflammatory bowel diseases - Diagnostic Test Results , Inflammatory bowel diseases - Other Diagnostic Test Results , Inflammatory bowel diseases - Other Diagnostic Test Results , Inflammatory bowel diseases - 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 - IMD Report - Scleroderma or Morphea; Dermatomyositis or Polymyositis; Diabetes mellitus Type I (Report Final and Annex Report 2 Final)

- 02.11.20 - 1 Formulier, 25 Itemgroepen, 95 Data-elementen, 1 Taal
Itemgroepen: Administrative, Scleroderma or Morphea, Scleroderma or Morphea - Signs and Symptoms, Scleroderma or Morphea - Other signs and symptoms, Scleroderma or Morphea - Other signs and symptoms , Scleroderma or Morphea - Diagnostic Test Results, Scleroderma or Morphea - Other Diagnostic Test Results , Scleroderma or Morphea - Other Diagnostic Test Results , Scleroderma or Morphea - Other diagnostic Procedure, Dermatomyositis or Polymyositis, Dermatomyositis or Polymyositis - Signs and symptoms (supporting the final diagnosis), Dermatomyositis or Polymyositis - Other Signs and symptoms, Dermatomyositis or Polymyositis - Other Signs and symptoms , Dermatomyositis or Polymyositis - Diagnostic Test Results, Dermatomyositis or Polymyositis - Other Diagnostic Test Results , Dermatomyositis or Polymyositis - Other Diagnostic Test Results , Dermatomyositis or Polymyositis - Other diagnostic Procedure , Diabetes mellitus type I, Diabetes mellitus type I - Signs and symptoms (supporting the final diagnosis), Diabetes mellitus type I - Other Signs and symptoms , Diabetes mellitus type I - Other Signs and symptoms , Diabetes mellitus type I - Diagnostic Test Results , Diabetes mellitus type I - Other Diagnostic Test Results , Diabetes mellitus type I - Other Diagnostic Test Results , Diabetes mellitus type I - 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 - Immune Mediated Disease Report; General Medical History; Relevant Risk Factors; Neurological Events; Myasthenia Gravis; Uveitis (Report Final and Annex Report 2 Final)

- 02.11.20 - 1 Formulier, 31 Itemgroepen, 114 Data-elementen, 1 Taal
Itemgroepen: Administrative, IMD Report, General Medical History, General Medical History , Relevant risk factors, Neurological Events, Neurological Events - Signs and Symptoms, Neurological Events - Signs and Symptoms - Seizures, Neurological Events - Signs and Symptoms, Neurological Events - Other signs and symptoms, Neurological Events - Other signs and symptoms , Neurological Events - Diagnostic Test Results, Neurological Events - Other Diagnostic Test Results , Neurological Events - Other Diagnostic Test Results , Neurological Events - Other diagnostic Procedure, Myasthenia Gravis, Myasthenia Gravis - Signs and symptoms (supporting the final diagnosis), Myasthenia Gravis - Other Signs and symptoms, Myasthenia Gravis - Other Signs and symptoms , Myasthenia Gravis - Diagnostic Test Results, Myasthenia Gravis - Other Diagnostic Test Results , Myasthenia Gravis - Other Diagnostic Test Results , Myasthenia Gravis - Other diagnostic Procedure , Uveitis, Uveitis - Signs and symptoms (supporting the final diagnosis), Uveitis - Other Signs and symptoms , Uveitis - Other Signs and symptoms , Uveitis - Diagnostic Test Results , Uveitis - Other Diagnostic Test Results , Uveitis - Other Diagnostic Test Results , Uveitis - 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 - Laboratory (Report Final and Annex Report 2 Final)

- 02.11.20 - 1 Formulier, 18 Itemgroepen, 95 Data-elementen, 1 Taal
Itemgroepen: Administrative, MAGE-A3 Expression Test: Screening, MAGE-A3 Expression Test: Screening - Result, MAGE-A3 Expression Test: Screening - Result , Laboratory Responsible Signature (MAGE-A3 Expression Test: Screening), MAGE-A3 Expression Test: Screening (Re-Test), MAGE-A3 Expression Test: Screening (Re-Test) - Result , MAGE-A3 Expression Test: Screening (Re-Test) - Result, Laboratory Responsible Signature (MAGE-A3 Expression Test: Screening (Re-Test)) , Gene Profiling: Screening, Gene Profiling: Screening , Laboratory Responsible Signature (Gene Profiling: Screening), MAGE-A3 Expression Test: Recurrence, MAGE-A3 Expression Test: Recurrence - Result, MAGE-A3 Expression Test: Recurrence - Result, Gene Profiling: Recurrence, Gene Profiling: Recurrence, Laboratory Responsible Signature (Gene Profiling: Recurrence)
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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