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Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Disease Staging Baseline

- 8/18/18 - 1 form, 5 itemgroups, 23 items, 1 language
Itemgroups: X-Ray Computed Tomography; Result | Diagnostic Imaging;Radiologic; Result, Bone Marrow Biopsy, Measurable Lymphoma Disease, Non- Measurable Disease, Administrative
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

Echocardiogram Week 38 Mepolizumab HES NCT00086658 - Echocardiogram Week 38

- 7/15/17 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Echocardiogram
Study part: Echocardiogram Week 38/ Early Withdrawal visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Echocardiogram Week 16 Mepolizumab HES NCT00086658 - Echocardiogram Week 16

- 7/12/17 - 1 form, 1 itemgroup, 3 items, 1 language
Itemgroup: Echocardiogram
Study part: Echocardiogram Week 16.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Echocardiogram Day 1 Pre-Infusion Mepolizumab HES NCT00086658 - Echocardiogram Day 1 Pre-Infusion

- 6/11/17 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Echocardiogram
Study part: Echocardiogram Day 1 Pre-Infusion.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Esophagogastroduodenoscopy Week 38 Mepolizumab HES NCT00086658 - Esophagogastroduodenoscopy Week 38

- 7/15/17 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Esophagogastroduodenoscopy
Study part: Esophagogastroduodenoscopy Week 38/ Early Withdrawal visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Esophagogastroduodenoscopy Week 16 Mepolizumab HES NCT00086658 - Esophagogastroduodenoscopy Week 16

- 7/12/17 - 1 form, 1 itemgroup, 3 items, 1 language
Itemgroup: Esophagogastroduodenoscopy
Study part: Esophagogastroduodenoscopy Week 16.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Esophagogastroduodenoscopy Day 1 Pre-Infusion Mepolizumab HES NCT00086658 - Esophagogastroduodenoscopy Day 1 Pre-Infusion

- 6/11/17 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Esophagogastroduodenoscopy
Study part: Esophagogastroduodenoscopy Day 1 Pre-Infusion.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

CT Scans Week 38 Mepolizumab HES NCT00086658 - CT Scans Week 38

- 7/15/17 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: CT Scans
Study part: CT Scans Week 38/ Early Withdrawal visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

CT Scans Day 1 Pre-Infusion Mepolizumab HES NCT00086658 - CT Scans Day 1 Pre-Infusion

- 6/11/17 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: CT Scans
Study part: CT Scans Day 1 Pre-Infusion.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

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).

Instrumental Diagnostics 12- Weeks Visits SirTac NCT02936388 - Instrumental Diagnostics 12- Weeks Visits

- 12/3/17 - 1 form, 1 itemgroup, 15 items, 1 language
Itemgroup: Instrumental Diagnostics
Study part: Instrumental Diagnostics 12- Weeks Visits. A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma. Provided by Prof. Dr. Ulrich Keilholz, Charité – University of medicine Berlin. EudraCT-Nummer: 2014-002439-32. NCT02936388.

Baseline MRI 12- Weeks Visits SirTac NCT02936388 - Baseline MRI 12- Weeks Visits

- 12/3/17 - 1 form, 3 itemgroups, 20 items, 1 language
Itemgroups: Baseline MRI, location liver, Non-target Lesions
Study part: Baseline MRI 12- Weeks Visits. A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma. Provided by Prof. Dr. Ulrich Keilholz, Charité – University of medicine Berlin. EudraCT-Nummer: 2014-002439-32. NCT02936388.

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