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 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. 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, 16 itemgroups, 68 items, 1 language
Itemgroups: Therapy cycle 10-13,Therapy after cycle,Propranolol,Propranolol therapy deviation,Celecoxib,Celecoxib deviation,Cyclophosphamide,Cyclophosphamide deviation,Vinblastine,Vinblastine deviation,Toxicity overview,Toxicity,Hospitalization,Comments,Transfusion,Footer module

Therapy and toxicity cycle > 13

16 itemgroups 68 items

Therapy and toxicity cycle 1-3

16 itemgroups 68 items

Therapy and toxicity cycle 4-6

16 itemgroups 68 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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