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AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients NCT00180102 - nach 2. Induktionstherapie

- 27.09.21 - 25 Formulare, 8 Itemgruppen, 84 Datenelemente, 1 Sprache

Itemgruppen: Shipping of Material, Blood count, Clinical Chemistry, Bone Marrow Morphology, Treatment outcome evaluation, Risk group, Planned first post remission treatment, Planned first post remission treatment

NCT00180102 AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia. Phase 4 Study Type:Interventional Study Design:Allocation: Randomized Intervention Model:Factorial Assignment Masking:None (Open Label) Primary Purpose:Treatment Medical Department I, University Hospital Carl Gustav Carus Dresden, Germany, 01307 Sponsors and Collaborators Technische Universität Dresden Principal Investigator:Gerhard Ehninger, MD University Hospital Carl Gustav Carus Dresden

nach 1. Induktionstherapie

8 Itemgruppen 79 Datenelemente

Ersterhebung

7 Itemgruppen 38 Datenelemente

2. Induktionstherapie - Unerwünschte Ereignisse CTC 3.0 -

2 Itemgruppen 13 Datenelemente

Diagnostik vor Therapiebeginn

4 Itemgruppen 67 Datenelemente

Induktionstherapie -Unerwünschte Ereignisse CTC 3.0-

2 Itemgruppen 13 Datenelemente

Eligibility criteria

2 Itemgruppen 19 Datenelemente

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Acute Myeloid Leukemia - Treatment Details

- 20.09.21 - 13 Formulare, 6 Itemgruppen, 39 Datenelemente, 1 Sprache

Itemgruppen: Therapeutic procedure; Details, Adverse Event, Hemopoietic stem cell transplant, Platelet Engraftment, Neutrophil Engraftment, Therapeutic procedure; Status

Acute Myeloid Leukemia Common Data Elements Holz

Medical History

6 Itemgruppen 20 Datenelemente

Lab: Cytology/Cytogenetics/Cytochemistry

3 Itemgruppen 43 Datenelemente

Lab: Molecular Genetics, Immunophenotyping, Cytogenetics

1 Itemgruppe 1 Datenelement

Physical Examination/Follow-up

4 Itemgruppen 27 Datenelemente

Lab: Infectiology

1 Itemgruppe 11 Datenelemente

Lab: Molecular Genetics

1 Itemgruppe 23 Datenelemente

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AML- Register_First diagnosis_SAL_University hospital dresden - First diagnosis

- 20.09.21 - 2 Formulare, 4 Itemgruppen, 40 Datenelemente, 1 Sprache

Itemgruppen: Patient information, Anamnesis status, Laboratory, Mutations

Items used as routine documentation for the SAL (Studienallianz Leukmie) study centre of university hospital dresden. ODM derived from original form "AML-Register Erstdiagnose-B1 und Komorbidität-B2", converted to ODM format.

Comorbidity

1 Itemgruppe 27 Datenelemente

Eligibility Acute Myeloid Leukemia NCT02483312

- 20.09.21 - 1 Formular, 2 Itemgruppen, 15 Datenelemente, 1 Sprache

Itemgruppen: Inclusion Criteria, Exclusion Criteria

A Study of IL-12 in Patients With Acute Myelogenous Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT02483312

Patient data AML Pazopanib NCT01361334

- 20.09.21 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 2 Sprachen

Itemgruppen: Patient data, Bisherige Behandlung AML: RQG

Pilot Clinical Trial of Pazopanib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or at Initial Diagnosis When no Intensive Treatment is Possible (PAZOPANIB-AML) https://clinicaltrials.gov/ct2/show/NCT01361334 Principal Investigator: PD Dr. Torsten Kessler, University Hospital Muenster, Germany

Registration and Randomization Form (HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26)

- 20.09.21 - 1 Formular, 4 Itemgruppen, 39 Datenelemente, 1 Sprache

Itemgruppen: Patient data, Patient consent, Eligibility, Data from HOVON data center

Randomized study with a run-in dose-selection phase to assess the added value of Lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score> 4.5) With friendly permission of HOVON-Group - Prof. G. Ossenkoppele

AML- Register_Registration form_SAL_University hospital dresden

- 20.09.21 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: Clinic information, Patient information

Items used as routine documentation for the SAL (Studienallianz Leukämie) study centre of university hospital dresden. ODM derived from original form "AML-Register Meldebogen - A", converted to ODM format.

Elements in Routine Documentation of AML Patients after Stem Cell Transplantation (HSCT), EHR, University Hospital Münster

- 20.09.21 - 1 Formular, 7 Itemgruppen, 134 Datenelemente, 1 Sprache

Itemgruppen: Patient data, Laboratory results, Diagnosis, Comorbidities, Disease response, Transplant, Microbiology

Elements in Routine Documentation of AML Patients after Stem Cell Transplantation (HSCT) at the University Hospital Münster, Centre for Stem Cell Transplanation. Data derived from a collection of anonymized Hospital discharge letters of Patients after HSCT and Diagnosis of Acute Myeolocytic Leukemia (AML). The Hospital discharge letters contain data of the Years 2014/2015.

Data elements in routine documentation of AML patients after stem cell transplantation (HSCT), EHR, University Hospital Knappschaftskrankenhaus Bochum-Langendreer

- 20.09.21 - 1 Formular, 7 Itemgruppen, 107 Datenelemente, 1 Sprache

Itemgruppen: Patient data, Laboratory results, Diagnosis, Comorbidities, Disease response, Transplant, Microbiology

Data elements in routine documentation of AML Patients after stem cell transplantation (HSCT) at the University Hospital Knappschaftskrankenhaus Bochum-Langendreer. Data derived from anonymized hospital discharge letters of patients after HSCT and diagnosis of Acute Myeolocytic Leukemia (AML). The documents contain data of the years 2014/2015.

Acute Leukaemia AML EBMT HSCT Registry MED-B Disease Specific Form

- 20.09.21 - 1 Formular, 13 Itemgruppen, 68 Datenelemente, 1 Sprache

Itemgruppen: Hospital Team, Patient, Disease, Initial Diagnosis, Cytgenetics, Molecular Biology, Involvement at Diagnosis, Type of HSCT, Treatment and Status of Disease at Stem Cell Collection, Status of Disease at HSCT, Additional Treatment Post-HSCT, Best disease response at 100 days post-HSCT, Forms to be filled in

The European Society for Blood and Marrow Transplantation maintains a huge registry and delivers data collection forms. The original forms for submitting data to the EBMT can be found under: http://www.ebmt.org/Contents/Data-Management/Registrystructure/MED-ABdatacollectionforms/Pages/MED-AB-data-collection-forms.aspx#HSCTMedB This ODM form is derived from the AML-disease specific form of the section MED-B. http://www.ebmt.org/Contents/Data-Management/Registrystructure/MED-ABdatacollectionforms/Documents/05AL.pdf

AML- Register_Accompanying Material Form_SAL_University hospital dresden

- 20.09.21 - 1 Formular, 3 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: Patient information, Material, Sender information

Items used as routine documentation for the SAL (Studienallianz Leukmie) study centre of university hospital dresden. ODM derived from original form "AML-Register Materialbegleitbogen für Biomaterialbank", converted to ODM format.

AML- Register_Progress sheet_SAL_University hospital dresden

- 20.09.21 - 1 Formular, 4 Itemgruppen, 21 Datenelemente, 1 Sprache

Itemgruppen: Patient information, Patient alive, death, recurrence

Items used as routine documentation for the SAL (Studienallianz Leukämie) study centre of university hospital dresden. ODM derived from original form "AML-Register Verlaufsbogen - C", converted to ODM format.

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