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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Visit 12 Galafold (migalastat) AT1001-012 NCT01218659

- 11/11/16 - 1 form, 17 itemgroups, 58 items, 1 language
Itemgroups: Date of visit, 12 Lead ECG, Hematology/Coagulation, clinically significant abnormal laboratory values Hematology, Chemistry, Laboratory findings, clinically significant abnormal laboratory values Chemistry, Urinanalysis, clinically significant abnormal laboratory values Urinalysis, 24-Hr Urine Collection, Additional Observations, Vital Signs 2, Echocardiography, SF-36 Health Survey, Modified Brief Pain Inventory, Secondary Endpoint Criteria, Drug log, Physical Examination
A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT Visit 12

QPNEU 16 Aufnahme University Hospital Muenster (UKM) Subform

- 11/10/16 - 1 form, 1 itemgroup, 16 items, 1 language
Itemgroup: admission
Hospital Routine Documentation Form at the University Hospital Muenster

QPNEU 16 Entlassung University Hospital Muenster (UKM) Subform

- 11/10/16 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: discharge, stabel status
Hospital Routine Documentation Form at the University Hospital Muenster

NO MS InfektionenSepsis University Hospital Muenster (UKM) Subform

- 11/10/16 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: sepsis, sepsis
Hospital Routine Documentation Form at the University Hospital Muenster

Vital Signs MS University Hospital Muenster (UKM) Subform

- 11/9/16 - 1 form, 1 itemgroup, 9 items, 1 language
Itemgroup: Vital Signs
Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: Vital Signs MS University Hospital Muenster (UKM) Subform.

QDEK 16 decubitus ulcers University Hospital Muenster (UKM) Subform

- 11/9/16 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: Decubitus ulcers
Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: QDEK 16 Dekubitus

Größe und Gewicht University Hospital Muenster (UKM) Subform

- 11/7/16 - 1 form, 1 itemgroup, 4 items, 2 languages
Itemgroup: Height and Weight
Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: Größe und Gewicht.

Screening and Observation Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 11/2/16 - 1 form, 8 itemgroups, 61 items, 2 languages
Itemgroups: In-/Exclusion Criteria, Demographics, Vital Signs and Examinations, Circulatory Symptoms, One year transfusion history, Preexisting and concomitant diseases, Preexisting and concomitant, Visit 0 - FACIT, Visit 0 - SF36
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

A. Disease and general conditions of the aftercare Questionnaire for aftercare ABC study - A. Disease and general conditions of the aftercare Questionnaire for aftercare

- 10/26/16 - 1 form, 10 itemgroups, 85 items, 1 language
Itemgroups: therapy blood cancer, Aftercare condition, Period aftercare, Medical Examination, medical support, Supportive care, relapse blood cancer, symptoms relapse blood cancer, Medical Examination Relapse blood cancer, therapy Relapse blood cancer
Study part: A. Disease and general conditions of the aftercare Questionnaire for aftercare ABC Study. Aftercare pattern in adult patients with blood cancer and blood cancer early stage: Impact on health related endpoints, quality of life and health resource use. University clinic essen, (Klinik für Hämatologie Uniklinik Essen, UKE), department hematology. Permission granted by Claudia Ose.

Early Termination Visit - Visit 17 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 10/25/16 - 1 form, 9 itemgroups, 37 items, 2 languages
Itemgroups: Date of Visit, LDH, Weight, Vital signs, Examinations, Six-Minute Walk Test, Circulatory Symptoms, Study medication, Signature principal investigator
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

DE Gew. Untersuchung LSTM Sub University Hospital Muenster (UKM) Subform

- 10/9/16 - 1 form, 1 itemgroup, 7 items, 1 language
Itemgroup: Required Examination
Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: DE Gew. Untersuchung LSTM Sub.

Follow-up F2 LeMLAR-Studie Lymphoma NCT01788189 - Follow-up F2

- 10/6/16 - 1 form, 2 itemgroups, 131 items, 1 language
Itemgroups: follow­ up, clinical examination Diagnostic Imaging Manifestation of Lymphoma
Study part: Follow-up F2 LeMLAR-Studie. Lenalidomide in conjunction with methotrexate, leucovorin, cytarabine and rituximab for the treatment of relapsed or refractory CD20-positive aggressive lymphomas: an open-label, multicenter phase I/II trial. Publication granted by Prof. Dührsen and provided by Claudia Ose, University clinic Essen, NCT01788189, Version 1.3-28.04.2013.doc.

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