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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 modulo, 25 itemgroups, 93 elementi, 1 linguaggio
Itemgroups: 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 modulo, 25 itemgroups, 95 elementi, 1 linguaggio
Itemgroups: 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 modulo, 31 itemgroups, 114 elementi, 1 linguaggio
Itemgroups: 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 modulo, 18 itemgroups, 95 elementi, 1 linguaggio
Itemgroups: 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

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Non-Serious Adverse Events; Study Conclusion (Report Final and Annex Report 2 Final)

- 02/11/20 - 1 modulo, 7 itemgroups, 31 elementi, 1 linguaggio
Itemgroups: Administrative, Non-Serious Adverse Event, Non-Serious Adverse Event , Death Form, Study Conclusion - Pregnancy Information, Study Conclusion, Study Conclusion - Investigator's Siganture
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 - Chronic and concomitant medication; Concomitant vaccination (Report Final and Annex Report 2 Final)

- 02/11/20 - 1 modulo, 5 itemgroups, 14 elementi, 1 linguaggio
Itemgroups: Administrative, Chronic and concomitant medication, Chronic and concomitant medication , Concomitant Vaccination, Concomitant Vaccination
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 - Yearly Follow-up contact; Anti Cancer Therapy (Report Final and Annex Report 2 Final)

- 30/10/20 - 1 modulo, 5 itemgroups, 11 elementi, 1 linguaggio
Itemgroups: Adminstrative, Yearly Follow-up - Check for Follow-up contact, End of yearly Follow-up contact, Anti-cancer therapy(ies) following last study treatment administration, Subsequent treatment
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 - Best overall response assessment; New tumor biopsy/ sample (Report Final and Annex Report 2 Final)

- 30/10/20 - 1 modulo, 3 itemgroups, 29 elementi, 1 linguaggio
Itemgroups: Administrative, Best overall response assessment, New tumor biopsy/ sample
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 - One Year Survival Assessment (Report Final and Annex Report 2 Final)

- 30/10/20 - 1 modulo, 2 itemgroups, 7 elementi, 1 linguaggio
Itemgroups: Administrative, One Year Survival Assessment
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 (Report Final and Annex Report 2 Final)

- 30/10/20 - 1 modulo, 14 itemgroups, 39 elementi, 1 linguaggio
Itemgroups: 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 - Radiotherapy; Local Surgery (Report Final and Annex Report 2 Final)

- 30/10/20 - 1 modulo, 5 itemgroups, 17 elementi, 1 linguaggio
Itemgroups: Administrative, Radiotherapy, Radiotherapy , Local Surgery, Local Surgery
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 - Treatment Conclusion (Report Final and Annex Report 2 Final)

- 30/10/20 - 1 modulo, 3 itemgroups, 9 elementi, 1 linguaggio
Itemgroups: Administrative, Pregnancy Information, Was the patient withdrawn from investigational product or did the patient not attend concluding visit?
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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