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Relevancia Evaluación Nuevo primero Antiguo primero

On-Study - Waldenstroms Macroglobulinemia - On-Study Form - 2273908v3.0 - Waldenstroms Macroglobulinemia - On-Study Form

- 17/9/21 - 1 formulario, 5 itemgroups, 57 items, 1 idioma
Itemgroups: CRF Header, Waldenstrom's: Form Administration, Waldenstrom's: Disease Description, Waldenstrom's: Prior Treatment, Waldenstrom's: Relapsed Disease
Waldenstrom's Macroglobulinemia - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D6795205-A4D9-0CD9-E034-0003BA12F5E7

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - End of Study

- 30/3/21 - 1 formulario, 5 itemgroups, 23 items, 1 idioma
Itemgroups: Administrative Data, Pregnancy information, End of study, End of study details, Signature
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. Per protocol, subjects are to be followed until the subject completes the observation phase, the subject withdraws consent or the subject dies. Subjects who do not complete the treatment phase, should be followed until they complete the observation phase, withdraw consent or die. This form has to be filled out at the end of study/ end of treatment.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Study Treatment

- 22/2/21 - 1 formulario, 5 itemgroups, 32 items, 1 idioma
Itemgroups: Administrative Data, Pre-Medications, Ofatumumab Infusion Summary Details, Infusion Vitals Details Entry, Treatment Confirmation
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 weekly visits during the treatment cycles.

dbGaP phs001284 NCI Waldenstrom Macroglobulinemia Genome-wide Association Study - Eligibility

- 23/3/23 - 5 formularios, 1 itemgroup, 3 items, 1 idioma
Itemgroup: IG.elig
Principal Investigator: Neil E Caporaso, MD, National Institutes of Health, Bethesda, MD, USA MeSH: Waldenstrom Macroglobulinemia,Lymphoplasmacytoid Lymphoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001284 A discovery GWAS is performed, consisting of genotyping 221 Waldenstrom macroglobulinemia (WM) cases on the Illumina Omni Express 12v1.1 platform and analyzing the genotypes together with those of 3798 previously genotyped controls in a model taking into account gender, age, and principal components of ancestry (i.e., significant eigenvectors). Directly genotyped data are supplemented by imputation using the Haplotype Reference Consortium.

pht009031.v1.p1

1 itemgroup 3 items

pht009032.v1.p1

1 itemgroup 3 items

pht009033.v1.p1

1 itemgroup 6 items

pht009034.v1.p1

1 itemgroup 5 items

Follow-Up - Waldenstroms Macroglobulinemia - Follow Up Form - 2274166v3.0 - Waldenstroms Macroglobulinemia - Follow Up Form

- 9/1/15 - 1 formulario, 6 itemgroups, 32 items, 1 idioma
Itemgroups: CRF Header, Waldenstrom's: Vital Status, Waldenstrom's: Disease Follow-Up Status, Waldenstrom's: Notice of Progression, Waldenstrom's: Notice of New Primary, Waldenstrom's: Long-Term Toxicity
Waldenstrom's Macroglobulinemia - Follow Up Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D67977AD-1633-1008-E034-0003BA12F5E7

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Investigational product discontinuation

- 30/3/21 - 1 formulario, 2 itemgroups, 5 items, 1 idioma
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 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 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.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Additional Scan

- 25/8/21 - 1 formulario, 2 itemgroups, 10 items, 1 idioma
Itemgroups: Administrative Data, Other protocol specified and/or additional scan
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 whenever/if additional scans have to be done during study.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Serious Adverse event

- 25/8/21 - 1 formulario, 15 itemgroups, 99 items, 1 idioma
Itemgroups: Administrative Data, Type of Report, Randomisation, Serious Adverse Event, Intensity Changes Entry, Seriousness of Adverse event, Relevant concomitant/Treatment medications Entry, Relevant medical conditions/Risk factors entry, Serious Adverse Event, Relevant Diagnostic Results Entry, Serious Adverse Event, Rechallenge, Investigational Product, Investigational Product, Investigational Product, Serious adverse event, General Narrative Comments, Serious Adverse Event, Non Clinical
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 whenever/if a serious adverse event occurred during study.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Pharmacogenetic Research

- 25/8/21 - 1 formulario, 3 itemgroups, 15 items, 1 idioma
Itemgroups: Administrative Data, Pharmacogenetic (PGx) Research Consent/Blood Sample Collection, Withdrawal of Consent for PGx (DNA) / Blood Sample Destruction
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 whenever/if Pharmacogenetic Research consent has to be given/withdrawn or blood samples have to be collected during study.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Blood products, blood supportive care and concomitant medication

- 25/8/21 - 1 formulario, 3 itemgroups, 24 items, 1 idioma
Itemgroups: Administrative Data, Blood Products and Blood Supportive Care Products (BLD), Concomitant Medications
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 whenever/if blood products, blood supportive care products or other concomitant medication is administered during study.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Non-serious Adverse event

- 10/8/21 - 1 formulario, 2 itemgroups, 27 items, 1 idioma
Itemgroups: Administrative Data, Non-serious adverse event
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 whenever/if a non-serious adverse event occurred during study. Use one form for each event.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Log Status

- 7/4/21 - 1 formulario, 2 itemgroups, 7 items, 1 idioma
Itemgroups: Administrative Data, Log Status
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 is for logging, if any concomitant medication, (non-)serious adverse events, blood (supportive care) products or additional scans occurred during the study.

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