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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
    1. 7.1. Anesthesiology
    1. 7.2. Dermatology
    1. 7.3. ENT
    1. 7.4. Geriatrics
    1. 7.5. Gynecology/Obstetrics
    1. 7.6. Internal Medicine
      1. Hematology
      1. Infectious Diseases
      1. Cardiology/Angiology
      1. Pneumology
      1. Gastroenterology
      1. Nephrology
      1. Endocrinology/Metabolic Diseases
      1. Rheumatology
    1. 7.7. Neurology
    1. 7.8. Ophthalmology
    1. 7.9. Palliative Care
    1. 7.10. Pathology/Forensics
    1. 7.11. Pediatrics
    1. 7.12. Psychiatry/Psychosomatics
    1. 7.13. Radiology
    1. 7.14. Surgery
      1. General/Visceral Surgery
      1. Neurosurgery
      1. Plastic Surgery
      1. Thoracic Surgery
      1. Trauma/Orthopedics
      1. Vascular Surgery
    1. 7.15. Urology
    1. 7.16. Dental Medicine/OMS
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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

Lab: Cytology/Cytogenetics/Cytochemistry

1 itemgroup 29 items

Lab: Immunophenotyping

1 itemgroup 17 items

Lab: Molecular Genetics

1 itemgroup 27 items

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Screening - Medical and Surgical History; Disease Stage at Study Entry; Classification of Disease at Study Entry; Cancer related Surgical History; Previous Anti-Neoplastic Therapy

- 2/27/19 - 1 form, 9 itemgroups, 26 items, 1 language
Itemgroups: Adminstrative, Does the subject have any clinically significant medical or surgical history?, Medical and Surgical History, Disease Stage at Study Entry, Classification of Disease at Study Entry, Did the subject have previous cancer related surgical history?, Cancer related Surgical History, Previous Anti-Neoplastic Therapy, Previous Anti-Neoplastic Therapy
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Prior Therapy

- 3/15/21 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Prior Therapy, Pharmaceutical Preparations, Therapeutic radiology procedure; Before
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Infusion Record Dosimetric Dose - Day 0 (Visit 2)

- 8/18/18 - 1 form, 9 itemgroups, 32 items, 1 language
Itemgroups: Date administered, HAMA, Time started, Time finished, Doses, Infusion rate, Record Vital Signs, Adverse Experience, Compliance
Study ID: 104507 Clinical Study ID: BEX104507 Study Title: Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphoma Patients who have Previously Received Rituximab Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996593 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Patient Enrollment/ Patient Eligibility - Demographics; General Medical History; Prior Therapy; History of Lymphoma

- 3/18/21 - 1 form, 13 itemgroups, 46 items, 1 language
Itemgroups: Administrative, Demographics (Enrollment), Investigator Signature, For Coulter Use Only, Demographics (General Medical History), Medical History Date, General Medical History, Prior Therapy, Prior Radiation Therapy, History of Lymphoma, Lymphoma Cell Type, Lymphoma Grade , History of Lymphoma
Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755 - Prior Therapy

- 7/12/18 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Administrative Data, xxx
Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin Please record all prior therapies for NHL (e.g. chemotherapy, immunotherapy, steroidal therapy).

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

- 2/11/16 - 1 form, 15 itemgroups, 60 items, 1 language
Itemgroups: At start of cylce, For Induction I only, Cycle, Cytarabine, Daunorubicin, Dasatinib, Events, Inpatient Hospitalisation during Cycle, MUGA/Echo Scan, Concomitant Medication, Buccal Swab (For Induction I only), Pregnancy test, Supportive Care, Hematological Regeneration, Signature
Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel™) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664 - Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7

- 5/23/18 - 1 form, 4 itemgroups, 56 items, 1 language
Itemgroups: Dosimetric Dose - Day 0, Vital Signs, Therapy Dose - Day 7, Vital Signs
https://clinicaltrials.gov/show/NCT00989664 Visit 2 - Infusion Record Dosimetric Dose Day 0 and Therapy Dose Day 7 Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Agent AML Pazopanib NCT01361334

- 2/11/16 - 1 form, 2 itemgroups, 14 items, 2 languages
Itemgroups: Medication Pazopanib, Medication Pazopanib
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

Last Pazopanib AML Pazopanib NCT01361334

- 2/11/16 - 1 form, 2 itemgroups, 18 items, 2 languages
Itemgroups: Last Pazopanib, Pazopanib abgesetzt: 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

1. Induktionstherapieblock EudraCT-Nr 2008-004583-40 Akute myeloische Leukämie(AML) AML alle außer FAB M3 - 1. Induktionstherapieblock

- 9/20/21 - 1 form, 17 itemgroups, 69 items, 2 languages
Itemgroups: Patientendaten, 5-Azacytidine - Dose no. 1, 5-Azacytidine - Dose no. 2, 5-Azacytidine - Dose no. 3, 5-Azacytidine - Dose no. 4, 5-Azacytidine - Dose no. 5, 5-Azacytidine dose reduction, Differentialblutbild, Chemotherapy, Ara-C , Daunorubicin, G-CSF, Cytopenia duration, leukopenia, neutropenia, thrombopenia, Unterschrift
A randomized, multi-center phase II trial to assess the efficacy of 5-azacytidine added to standard primary therapy in elderly patients with newly diagnosed AML

AMC-070 Off-Study Summary Form (F50)

- 10/9/17 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: Off-Study Summary
AMC-070 Off-Study Summary Form (F50) Lenalidomide in Treating Patients With AIDS-Related Kaposi Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=91E448E8-A18B-E89F-E040-BB89AD433766

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