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Table of contents
  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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26672_Common Data Elements Myeloid Leukemia (MDS AML CML) - Global Disease Course

- 9/20/21 - 13 forms, 3 itemgroups, 11 items, 1 language
Itemgroups: Global Disease Course,Red Cell Transfusion,Platelet Cell Transfusion
Common Data Elements Myeloid Leukemia (MDS, AML, CML) for use in clinical routine and clinical trial documentation. https://www.ncbi.nlm.nih.gov/pubmed/27577388

Physical Examination/Follow up

3 itemgroups 14 items

Administrative/Demographic Details

1 itemgroup 11 items

Medical History

3 itemgroups 9 items

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment

- 11/18/21 - 9 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: Subject details
Study documentation part: On- Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

On-Treatment 1

15 itemgroups 84 items

On-Treatment 2

13 itemgroups 62 items

On-Treatment 4

12 itemgroups 62 items

Follow-up AMLSG 21-13 DRKS00007189 NCT02013648 Akute myeloische Leukämie (AML) - Follow-up AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

- 11/17/21 - 1 form, 5 itemgroups, 22 items, 1 language
Itemgroups: Follow-up,Concomitant Disease,Therapy,Allogenic Transplantation,Signature
Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel(TM)) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

On-Study - Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients - 2019420v3.0 - Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients

- 9/27/21 - 1 form, 4 itemgroups, 33 items, 1 language
Itemgroups: CRF Header,AML/MDS: Form Administration,AML/MDS: Disease Description,Comments
Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Previously Untreated Patients Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B24E8B9-F86C-508D-E044-0003BA3F9857

Leukemia NCT00085124 On-Study - CALGB: 10201On-Study Form - 2057573v3.0 - CALGB: 10201On-Study Form

- 9/27/21 - 1 form, 6 itemgroups, 39 items, 1 language
Itemgroups: CALGB Form,Patient Description,Organ Involvement,Current Symptoms,Lab data at Study Entry,CCRR MODULE
CALGB: 10201On-Study Form Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD838530-D422-2F4D-E034-0003BA12F5E7

Eligibility DRKS00003796 NCT01209286 B-ALL - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 15 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01209286

Swedish MDS registry - Myelodysplastic Syndrome - Registration

- 9/27/21 - 2 forms, 13 itemgroups, 76 items, 2 languages
Itemgroups: Registration form,Lead times,Diagnosis,Biobank,PREVIOUS DISEASE,Transfusions,Blood samples at diagnosis,Bone marrow at diagnosis,Cytogenetics at diagnosis,IPSS,Diagnosis reason,Treatment,Follow-Up
Source: Swedish National Quality Registry for Leukaemia http://www.cancercentrum.se/samverkan/cancerdiagnoser/blod-lymfom-myelom/

Myelodysplastic Syndrome - Follow-Up

10 itemgroups 83 items

Eligibility DRKS00005163 NCT01207388 B-ALL - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 14 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01207388

Eligibility NCT01018069 Leukemia - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 19 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01018069

Eligibility NCT00989261 Acute Myeloid Leukemia - Eligibility AML NCT00989261

- 9/27/21 - 1 form, 2 itemgroups, 37 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations see http://clinicaltrials.gov/show/NCT00989261

Eligibility NCT01035502 Acute Myeloid Leukemia - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 24 items, 2 languages
Itemgroups: Inclusion Criteria,Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01035502

AML- Register_First diagnosis_SAL_University hospital dresden - First diagnosis

- 9/20/21 - 2 forms, 4 itemgroups, 40 items, 1 language
Itemgroups: 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 itemgroup 27 items

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