Keywords
Diagnostic Imaging ×
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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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- 11/26/21 - 1 form, 11 itemgroups, 61 items, 1 language
Itemgroups: Date of hepatic or liver imaging test,method used for imaging test,images technically adequate,liver size,liver texture,diffuse and/or geographic fatty infiltrate of the liver,Ascites present,Focal Hepatic Lesions characterisable,Gallstones or gallbladder lesions,Biliary ductal lesions,Portal/Hepatic vein abnormalities
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 ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 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. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver imaging is performed (in case of a liver event).
- 9/20/21 - 16 forms, 12 itemgroups, 78 items, 1 language
Itemgroups: Response to treatment,General assessment,Cardiology discipline examination,Lab results,Tumor Markers,Staging,local MRT/ CT examination,mIBG,Bone marrow examination,Ohter examination,Overall assessment,Footer module

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12 itemgroups 78 items

Study relevant visits

12 itemgroups 78 items

Second malignancy

12 itemgroups 78 items
- 9/20/21 - 1 form, 23 itemgroups, 256 items, 1 language
Itemgroups: Date of visit,Demographics,National origin,Mother tongue,Clinical diagnosis,Living situation,Education and profession,Consumption of semiluxury food - nicotine,Consumption of semiluxury food - alcohol,Vital signs,Clinical phenotype - Anamnesis and inspection,Clinical phenotype - Further examination,Umsars I: Questions 9-12,Anamnesis motor skills,Montreal Cognitive Assessment (MoCA),Geriatric depression scale (GDS),Sampling - Blood collection,Sampling according to SOP,Registration of samples,Sampling - Urine sample,Sampling according to SOP (Urine),Results of urine strips,Registration of samples (Urine)

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