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Checklist Kidney Transplant Urology Department Transplant Center Clinic Bremen-Mitte - Checklist- Examinations for the registration of transplant

- 2016-04-24 - 1 Formulär, 1 Item-grupp, 54 Dataelement, 2 Språk
Item-grupp: Medical Examination
Item used as routine documentation by Clinic Bremen-Mitte, Urology Department, Kidney transplant. ODM derived from form “C H E C K L I S T E - Untersuchungen zur Transplantationsanmeldung” Number TPLF006, Version 3, Transplant Center Bremen, Clinic Bremen-Mitte gGmbH 28177 Bremen, Germany.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Unscheduled Assessments

- 2021-02-24 - 1 Formulär, 2 Item-grupper, 12 Dataelement, 1 Språk
Item-grupper: Administrative Data, Unscheduled Assessments
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. This form has to be filled out at any unscheduled visits.

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