Search results - Portal of Medical Data Models (MDM-Portal)

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Laboratory Tests

- 8/16/19 - 1 form, 5 itemgroups, 31 items, 1 language

Itemgroups: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Blood Chemical Analysis, Laboratory Procedures, Urinalysis, Laboratory Procedures, Correlative Study, Tissue specimen

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Liver imaging

- 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).

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Liver Events

- 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.