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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 Formular, 25 Itemgruppen, 95 Datenelemente, 1 Sprache
Itemgruppen: 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 Formular, 4 Itemgruppen, 29 Datenelemente, 1 Sprache
Itemgruppen: 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 Formular, 4 Itemgruppen, 29 Datenelemente, 1 Sprache
Itemgruppen: 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 - Screening - MAGE-A3 Expression Test; Tumor Sample (For Re-Test); MAGE-A3 Expression Re-Test; Prior Surgery; Prior Therapy

- 17.09.21 - 1 Formular, 8 Itemgruppen, 50 Datenelemente, 1 Sprache
Itemgruppen: Administrative, MAGE-A3 Expression Test, Tumor Sample (For Re-Test), MAGE-A3 Expression Re-Test, Prior Surgery, Prior Surgery Type, Prior Therapy, Prior treatment with systemic immunosuppressants
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 - MAGE-A3 Expression Test; Tumor Sample (For Re-Test); MAGE-A3 Expression Re-Test; Prior Surgery; Prior Therapy (Annex Report 2 Final)

- 17.09.21 - 1 Formular, 9 Itemgruppen, 51 Datenelemente, 1 Sprache
Itemgruppen: Administrative, MAGE-A3 Expression Test, Tumor Sample (For Re-Test), MAGE-A3 Expression Re-Test, Prior Surgery, Prior Surgery Type, Prior Surgery, Prior Therapy, Prior treatment with systemic immunosuppressants
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 Formular, 8 Itemgruppen, 31 Datenelemente, 1 Sprache
Itemgruppen: 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 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: 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 Formular, 23 Itemgruppen, 85 Datenelemente, 1 Sprache
Itemgruppen: 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 Formular, 26 Itemgruppen, 97 Datenelemente, 1 Sprache
Itemgruppen: 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 - Idiopathic Thrombocytopenic Purpura; Pernicious Anaemia; Vasculitis (Report Final and Annex Report 2 Final)

- 03.11.20 - 1 Formular, 25 Itemgruppen, 91 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Idiopathic Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura - Signs and Symptoms, Idiopathic Thrombocytopenic Purpura - Other signs and symptoms, Idiopathic Thrombocytopenic Purpura - Other signs and symptoms , Idiopathic Thrombocytopenic Purpura - Diagnostic Test Results, Idiopathic Thrombocytopenic Purpura - Other Diagnostic Test Results , Idiopathic Thrombocytopenic Purpura - Other Diagnostic Test Results , Idiopathic Thrombocytopenic Purpura - Other diagnostic Procedure, Pernicious Anaemia, Pernicious Anaemia - Signs and symptoms, Pernicious Anaemia - Other Signs and symptoms, Pernicious Anaemia - Other Signs and symptoms , Pernicious Anaemia - Diagnostic Test Results, Pernicious Anaemia - Other Diagnostic Test Results , Pernicious Anaemia - Other Diagnostic Test Results , Pernicious Anaemia - Other diagnostic Procedure , Vasculitis, Vasculitis - Signs and symptoms, Vasculitis - Other Signs and symptoms , Vasculitis - Other Signs and symptoms , Vasculitis - Diagnostic Test Results , Vasculitis - Other Diagnostic Test Results , Vasculitis - Other Diagnostic Test Results (i.e. Serological viral hepatic tests, Serological liver enzymes), Vasculitis - 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 Formular, 25 Itemgruppen, 87 Datenelemente, 1 Sprache
Itemgruppen: 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 Formular, 25 Itemgruppen, 93 Datenelemente, 1 Sprache
Itemgruppen: 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

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