- 11/26/21 - 1 form, 4 itemgroups, 9 items, 1 language
Itemgroups: Administrative Data,Blood sample,Neuro Antibody panel,Prognostic factors
- 11/26/21 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: Administrative Data,Dosing date and time,PK Blood Sample
- 11/26/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Administrative Data,Vital Signs
- 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).
- 8/30/21 - 1 form, 10 itemgroups, 57 items, 1 language
Itemgroups: Administrative Data,Liver chemistry result,Liver events,Liver Pharmacokinetics,Liver investigational product,Liver disease medical conditions,Drug related liver disease conditions,Other liver disease conditions,Other medical conditions,Alcohol intake
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 events occur.
- 8/25/21 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Administrative Data,Other protocol specified and/or additional scan
- 8/25/21 - 1 form, 3 itemgroups, 15 items, 1 language
Itemgroups: Administrative Data,Pharmacogenetic (PGx) Research Consent/Blood Sample Collection,Withdrawal of Consent for PGx (DNA) / Blood Sample Destruction
- 8/25/21 - 1 form, 3 itemgroups, 24 items, 1 language
Itemgroups: Administrative Data,Blood Products and Blood Supportive Care Products (BLD),Concomitant Medications
- 8/25/21 - 1 form, 15 itemgroups, 99 items, 1 language
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
- 8/11/21 - 1 form, 3 itemgroups, 24 items, 1 language
Itemgroups: Administrative Data,Waldenstrom's Histology,Lymphoplasmacytic lymphoma histology
- 8/10/21 - 1 form, 2 itemgroups, 27 items, 1 language
Itemgroups: Administrative Data,Non-serious adverse event
- 4/7/21 - 1 form, 2 itemgroups, 7 items, 1 language
Itemgroups: Administrative Data,Log Status

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