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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Local Lab Assessments

- 16/3/21 - 1 formulario, 3 itemgroups, 13 items, 1 idioma

Itemgroups: Administrative Data, Laboratory Information, Local Lab 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 the screening visit, the first and last weekly visits during treatment cycles (week 1 and week 4), cycle observation visits, possible unscheduled and withdrawal visits.

Basic documentation B2 LeMLAR-Studie Lymphoma NCT01788189 - Basic documentation B2

- 15/3/21 - 1 formulario, 3 itemgroups, 26 items, 1 idioma

Itemgroups: medical history, Inclusion Criteria, Exclusion Criteria

Study part: Basic documentation B2 LeMLAR-Studie. LeMLAR-Studie. Lenalidomide in conjunction with methotrexate, leucovorin, cytarabine and rituximab for the treatment of relapsed or refractory CD20-positive aggressive lymphomas: an open-label, multicenter phase I/II trial. Publication granted by Prof. Dührsen and provided by Claudia Ose, University clinic Essen, NCT01788189, Version 1.3-28.04.2013.doc.

AML Discharge Letter Example I UKM

- 15/3/21 - 1 formulario, 14 itemgroups, 36 items, 1 idioma

Itemgroups: Administrative Data, Diagnosis, Secondary Diagnoses, Allergies, Therapy and course of disease, Current reason for presentation, Immunophenotyping, Medical History, Physical Examination, Lab Results, Apparative Diagnostics, Inpatient Treatment, Medication List, Procedures

AML Discharge Letter Example I UKM provided by PD Schliemann.

AML Discharge Letter Example V UKM

- 15/3/21 - 1 formulario, 13 itemgroups, 43 items, 1 idioma

Itemgroups: Administrative Data, Diagnosis, Secondary Diagnoses, Allergies, Therapy and course of disease, Current reason for presentation, Medical History, Physical Examination, Lab Results, Apparative Diagnostics, Inpatient Treatment, Medication List, Procedures

AML Discharge Letter Example V UKM provided by PD Schliemann.

Swedish National Quality Registry for Lymphoma (Nationellt kvalitetsregister för lymfom) - Registration form and cancer report (Anmälningsblankett och canceranmälan)

- 15/3/21 - 1 formulario, 5 itemgroups, 82 items, 1 idioma

Itemgroups: Administrative Data, Diagnosis, Primary Treatment, Disease Stage, Prognostic factors

Part of Swedish National Quality Registry for Blood Cancer source: https://www.cancercentrum.se/samverkan/cancerdiagnoser/blod-lymfom-myelom/lymfom-lymfkortelcancer/kvalitetsregister/ Leader of Registry: Karin Ekström Smedby, Karolinska Universitetssjukhuset Solna Chairman: Mats Jerkeman, Skånes universitetssjukhus, mats.jerkeman@skane.se This Registration form is valid from 2012-03-15. The form must be completed and submitted shortly after completion of the investigation to the Regional Cancer Center (Regionalt Cancercentrum).

Swedish National Quality Registry for Lymphoma (Nationellt kvalitetsregister för lymfom) - Primary Treatment (Primärbehandling)

- 15/3/21 - 1 formulario, 5 itemgroups, 54 items, 1 idioma

Itemgroups: Administrative Data, Diagnosis, Primary Treatment, Completed primary treatment, Additional Treatment (Complementary to primary treatment)

Part of Swedish National Quality Registry for Blood Cancer source: https://www.cancercentrum.se/samverkan/cancerdiagnoser/blod-lymfom-myelom/lymfom-lymfkortelcancer/kvalitetsregister/ Leader of Registry: Karin Ekström Smedby, Karolinska Universitetssjukhuset Solna Chairman: Mats Jerkeman, Skånes Universitetssjukhus, mats.jerkeman@skane.se This Primary Treatment form is valid from 2012-03-15. The form must be completed and submitted after completion of treatment or at the latest 1 year after diagnosis to: Regional Cancer Center in the respective region. If active tumor treatment is not given, the form must be filled in every two years until treatment is given.

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

- 15/3/21 - 1 formulario, 3 itemgroups, 15 items, 1 idioma

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 - Concomitant Medications and Transfusions and Adverse Experiences

- 15/3/21 - 1 formulario, 5 itemgroups, 27 items, 1 idioma

Itemgroups: Administrative, Concomitant Medications and Transfusions, Adverse event, Adverse event, Investigator Signature

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

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Unscheduled Assessments

- 24/2/21 - 1 formulario, 2 itemgroups, 12 items, 1 idioma

Itemgroups: 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.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - CT Assessment

- 22/2/21 - 1 formulario, 3 itemgroups, 11 items, 1 idioma

Itemgroups: Administrative Data, CT Assessment Questions, Lymph Node CT 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. Both of these forms have to be filled out at the observation visits for the cycles of treatment and possible unscheduled visits. The Lymph Node CT Assessments form also has to be filled out at a possible withdrawal visit.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Retreatment Question

- 22/2/21 - 1 formulario, 2 itemgroups, 3 items, 1 idioma

Itemgroups: Administrative Data, Retreatment Question

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 the observation visit of the first treatment cycle.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - New Lymph Node Assessment

- 22/2/21 - 1 formulario, 2 itemgroups, 11 items, 1 idioma

Itemgroups: Administrative Data, New Lymph Node Assessment Details

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 the observation visits for the cycles of treatment and possible unscheduled visits.

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