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Relevancia Evaluación Nuevo primero Antiguo primero

REGIMS Multiple Sclerosis Immunotherapy Registry Version 2016 - Baseline Main Sheet

- 20-09-21 - 9 formularios, 25 itemgroups, 116 items, 2 idiomas
Itemgroups: Ein-Ausschlusskriterien, Patientendaten, Krankheitsspezifische Angaben, EDSS-Score vor 12 Monaten, Heutige Scores der Funktionssysteme, Frühere verlaufsmodifizierende MS-Therapien, Aktuelle MS-Therapie, WeitereErkrankungen, Herz- / Kreislauferkrankungen, Stoffwechselerkrankungen, Infektionserkrankungen, Gastrointestinale Erkrankungen, Neurologische / Psychiatrische Erkrankungen, Allergien, Urogenitale Erkrankungen, Autoimmunerkrankungen, Blutbild / Labor, Allgemeine Symptome, Operation, Krebserkrankungen, Welche Therapien wurden aufgrund der Krebserkrankung durchgeführt?, Andere Erkrankung, Keine Vorerkrankungen aus diesen obigen Krankheitsgruppen/Erkrankungen bekannt, Schwangerschaft, Biologisches Material (z.B. Blut)
REGIMS is a registry of the administration, adverse events and benefit of immunotherapeutic agents in patients with Multiple Sclerosis. REGIMS is a project from the Institute of Epidemiology and Social Medicine of the University of Muenster, publication granted by Prof. Dr. Berger. For further information (in German), please view http://campus.uni-muenster.de/index.php?id=6075 or http://www.kompetenznetz-multiplesklerose.de/aktuelle-studien/regims. REGIMS ist ein Immuntherapieregister zur Verbesserung der Arzneimittelsicherheit in der Multiple Sklerose Therapie innerhalb des krankheitsbezogenen Kompetenznetzes MS. Das primäre Ziel von REGIMS ist die Erfassung der Häufigkeit, Charakteristika und Auswirkungen von Nebenwirkungen aktueller und neuer Immuntherapien in der klinischen Routinebehandlung der MS. Sekundäre Ziele sind die Auswertung von Faktoren, die a) mit Nebenwirkungen und b) mit guter Therapie-Adhärenz assoziiert sind. Optional können bei Zustimmung der Patienten Blutproben für die Biobank des KKNMS gesammelt werden. Patienten mit Multipler Sklerose (MS) weisen trotz des chronischen Verlaufs eine große Heterogenität klinischer Symptome, in Befunden der Bildgebung sowie pathophysiologischen Prozessen auf. Faktoren, die zur individuellen Krankheitsprognose beitragen sind kaum bekannt, jedoch hat die Einführung neuer Substanzen die Therapiemöglichkeiten der MS in den letzten Jahren deutlich erweitert. Die Anwendung sogenannter Immuntherapeutika (inklusive der neuen Substanzklasse der Biologika) bietet in der MS-Therapie eine Reihe von Chancen, birgt aber auch Risiken.

Baseline Pregnancy Part 1

5 itemgroups 24 items

Follow Up Pregnancy Part 1

5 itemgroups 24 items

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 formulario, 25 itemgroups, 95 items, 1 idioma
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 - IMD Report - Autoimmune Liver Diseases; Sarcoidosis; Other diseases (Report Final and Annex Report 2 Final)

- 03-11-20 - 1 formulario, 23 itemgroups, 85 items, 1 idioma
Itemgroups: 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 - Idiopathic Thrombocytopenic Purpura; Pernicious Anaemia; Vasculitis (Report Final and Annex Report 2 Final)

- 03-11-20 - 1 formulario, 25 itemgroups, 91 items, 1 idioma
Itemgroups: 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 - Screening - Laboratory Tests (Annex Report 2 Final)

- 28-10-20 - 1 formulario, 8 itemgroups, 16 items, 1 idioma
Itemgroups: 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 - Laboratory Tests

- 25-08-20 - 1 formulario, 8 itemgroups, 16 items, 1 idioma
Itemgroups: 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 - Laboratory Reference Ranges, Use of Human Samples by GSK, Investigator's Signature (Report Final and Annex Report 2 Final)

- 03-11-20 - 1 formulario, 8 itemgroups, 31 items, 1 idioma
Itemgroups: 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 - Check for Study Continuation; Physical Examination; Laboratory Tests (Report Final and Annex Report 2 Final)

- 29-10-20 - 1 formulario, 43 itemgroups, 93 items, 1 idioma
Itemgroups: Administrative, Check for Study Continuation (Visit 1), Check for Study Continuation (Visit 2) , Check for Study Continuation (Visit 3) , Check for Study Continuation (Visit 4), Check for Study Continuation (Visit 5) , Check for Study Continuation (Visit 6) , Check for Study Continuation (Visit 7) , Check for Study Continuation (Visit 8) , Check for Study Continuation (Visit 9) , Check for Study Continuation (Visit 10) , Check for Study Continuation (Visit 11) , Check for Study Continuation (Visit 12) , Check for Study Continuation (Visit 13), Check for Study Continuation (Visit 14), Check for Study Continuation (Visit 15) , Check for Study Continuation (Visit 16) , Check for Study Continuation (Visit 17) , Check for Study Continuation (Visit 18) , Check for Study Continuation (Visit 19) , Check for Study Continuation (Visit 20) , Check for Study Continuation (Visit 21) , Check for Study Continuation (Visit 22), Check for Study Continuation (Visit 23) , Check for Study Continuation (Visit 24) , Check for Study Continuation (Visit 25), Check for Study Continuation (Visit 26), Check for Study Continuation (Visit 27), Check for Study Continuation (Visit 28) , Check for Study Continuation (Follow-Up) , Physical Examination (Visit 1), Physical Examination (Visit 2 - 6, 8 - 13, 15 - 18, 20 - 28), Physical Examination (Follow-Up) , Weight (Visit 1 - 6, 8 - 13, 15 - 18, 20 - 28, Follow-Up), Laboratory Tests (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28), Haematology (Visit 1, 3, 6, 8, 10, 14 - 18, 20 - 28), Hepatic Function (Visit 1, 3, 6, 8, 10, 14 -18, 21, 23 - 28), Biochemistry (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28), Renal Function (Visit 1, 3, 6, 8, 10, 14 - 18, 21, 23 - 28), Humoral Immunity (Serum) (Visit 1, 3, 7, 14, 19, 21, 23 - 28, Follow-Up), Cellular Immunity (PBMC) (Visit 1, 7, 14, 19, 21, 23 - 26, 28, Follow-Up), HCG Urine or Blood Pregnancy Test (Visit 7, 11, 15, 17, 20 - 27), End of 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

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