Clinical Trial, Phase II ×
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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    2. 1.2. Medical History
    3. 1.3. Physical Examination
    4. 1.4. Assessment Score
    5. 1.5. Apparative Diagnostics
    6. 1.6. Laboratory
    7. 1.7. Pathology/Histology
    8. 1.8. Consent
    9. 1.9. Therapy
    10. 1.10. Operative Report
    11. 1.11. Adverse Event
    12. 1.12. Follow-Up
  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
Selected data models

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- 4/7/21 - 1 form, 2 itemgroups, 7 items, 1 language
Itemgroups: Administrative Data, Log Status
- 3/30/21 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: Administrative Data, Investigational Product Discontinuation
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on Identifier: NCT00811733 Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the end of study/ end of treatment. Complete this Form when the subject permanently stops the investigational product (IP). If the subject decided to withdraw consent and stop participation in the study, also complete the End of Study Form. If the subject decided to permanently stop the investigational product but will be followed for disease progression or survival per protocol, do not complete the End of Study Form until follow-up is complete.
- 3/30/21 - 1 form, 5 itemgroups, 23 items, 1 language
Itemgroups: Administrative Data, Pregnancy information, End of study, End of study details, Signature
- 3/16/21 - 1 form, 3 itemgroups, 13 items, 1 language
Itemgroups: Administrative Data, Laboratory Information, Local Lab Assessments
- 3/15/21 - 1 form, 15 itemgroups, 150 items, 2 languages
Itemgroups: Previous chemotherapy, Comorbidities, Symptoms, Physical Examination, Complete Blood Count, Biochemistry, Serum Proteins, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), Molecular Biology (peripheral blood), FISH (peripheral blood)
- 3/15/21 - 1 form, 24 itemgroups, 129 items, 2 languages
Itemgroups: Header, Eligibility Question, Demography, Physical examination, Disease Characteristics, Metastatic Disease Site, local laboratory, Residual toxicities related to previous therapy for cancer, Residual toxicities, Cancer related current medical conditions, Medical Conditions, non-cancer related medical conditions, Medical Conditions, Prior anti-cancer therapy, Prior anti-cancer therapy - medication, Prior anti-cancer therapy - radiotherapy, Vital signs, ECOG Performance Status Scale, 12 LEAD ECG, 12-lead ECG Abnormalities, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Electronically transferred laboratory data
- 2/22/21 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: Administrative Data, CT Assessment Questions, Lymph Node CT Assessments
- 2/22/21 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Administrative Data, New Lymph Node Assessment Details
- 2/22/21 - 1 form, 5 itemgroups, 32 items, 1 language
Itemgroups: Administrative Data, Pre-Medications, Ofatumumab Infusion Summary Details, Infusion Vitals Details Entry, Treatment Confirmation