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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Primary Tumor Characteristics; Regional Lymph Node Status; Tumor Sample (Annex Report 2 Final Annex Report 2 Final)

- 20-09-21 - 1 Formulier, 4 Itemgroepen, 27 Data-elementen, 1 Taal
Itemgroepen: Administrative, Primary Tumor Characteristics, Regional Lymph Node Status, Tumor Sample
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - Primary Tumor Characteristics; Regional Lymph Node Status; Tumor Sample

- 17-09-21 - 1 Formulier, 4 Itemgroepen, 27 Data-elementen, 1 Taal
Itemgroepen: Administrative, Primary Tumor Characteristics, Regional Lymph Node Status, Tumor Sample
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

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

- 22-02-21 - 1 Formulier, 2 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: 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.

Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874 - Lymph node examination

- 20-03-19 - 1 Formulier, 3 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Lymph node examination (for axillary and supraclavicular), Lymph node examination (for other lymph nodes localisation)
Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Lymph node examination form. It has to be filled in for screening and for all Visits (Visit 1-6).

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Screening Visit: Physical Examination

- 14-11-18 - 1 Formulier, 2 Itemgroepen, 29 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Physical Examination
Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

AMC-075 Lymphoma Disease Activity and Measurement Form (L01)

- 09-10-17 - 1 Formulier, 5 Itemgroepen, 17 Data-elementen, 1 Taal
Itemgroepen: Header - Lymphoma Disease Activity and Measurement Form, Reporting Period, Nodal Involvement Evaluation, Extra Nodal Involvement Evaluation, Comments
AMC-075 Lymphoma Disease Activity and Measurement Form (L01) Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With Previously Untreated HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9F166B5D-4C13-06F1-E040-BB89AD434FAE

Restaging PETAL Study NCT00554164 - Restaging

- 22-11-16 - 1 Formulier, 9 Itemgroepen, 63 Data-elementen, 2 Talen
Itemgroepen: Patient demographics, Staging, Lab results, Nodal involvement, Extranodal involvement, Overall result, Dscontinuation of therapy, IPI, Footer module
Positronen-Emissionstomographie-gesteuerte Therapie aggressiver Non-Hodgkin-Lymphome (PETAL-Studie) Universitätsklinikum Essen (UK Essen) EudraCT-Nummer: 2006-001641-33 NCT00554164

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