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Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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101 Search results.

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Best overall response assessment; New tumor biopsy/ sample (Report Final and Annex Report 2 Final)

- 10/30/20 - 1 form, 3 itemgroups, 29 items, 1 language
Itemgroups: Administrative, Best overall response assessment, New tumor biopsy/ 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

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Response Assessment

- 8/20/19 - 1 form, 4 itemgroups, 12 items, 1 language
Itemgroups: Administrative documentation, TNM clinical staging, Rectal Carcinoma, Pathological staging, Rectal Carcinoma, Sphincter, Preservation technique
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

Cisplatin and Topotecan Recurrent on Persistent Carcinoma of the Cervix - 103369 - Drug Dose Form

- 3/14/19 - 1 form, 6 itemgroups, 38 items, 1 language
Itemgroups: Administrative data, Investigational Product, Drug Dose, Tumor Measurements, Best Tumor Response, Pre-treatment Hematologies and Chemistries
Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - SRT501 + Bortezomib Cycle __ Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 3/10/19 - 1 form, 23 itemgroups, 107 items, 1 language
Itemgroups: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Result, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, Radiographic Assessment, Radiographic Assessment , Disease Marker Assessment , Disease Marker Assessment , Disease Response, Study Treatment Compliance (Return) , New Adverse Events and Concomitant Treatment
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - SRT501, Monotherapy, Cycle __ Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 3/10/19 - 1 form, 23 itemgroups, 109 items, 1 language
Itemgroups: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Result, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, Radiographic Assessment, Radiographic Assessment , Disease Marker Assessment , Disease Marker Assessment , Disease Response, Study Treatment Compliance (Return) , New Adverse Events and Concomitant Treatment
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Cycle 2 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment; Disease Response; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 3/1/19 - 1 form, 23 itemgroups, 109 items, 1 language
Itemgroups: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Result, ECG Findings, Hematology, Hematology , Clinical Chemistry, Coagulation and Electrolytes, Clinical Chemistry, Coagulation and Electrolytes , Urinalysis dipstick results, Urinalysis microscopy results, Urinalysis microscopy results , Serum beta-hCG Pregnancy Test, Radiographic Assessment, Radiographic Assessment , Disease Marker Assessment, Disease Marker Assessment , Disease Response, Study Treatment Compliance (Return) , New Adverse Events and Concomitant Treatment
Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Independent Response Evaluation Oncologist's Assessment and Consensus Criteria

- 8/18/18 - 1 form, 3 itemgroups, 8 items, 1 language
Itemgroups: Post- Treatment Response, Consensus Criteria, 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

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Independent Response Evaluation Joint Assessment and Consensus Criteria

- 8/18/18 - 1 form, 3 itemgroups, 10 items, 1 language
Itemgroups: Independent Response Evaluation, Consensus Criteria, 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

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Independent Response Evaluation Radiologist's Assessment and Consensus Criteria

- 8/18/18 - 1 form, 5 itemgroups, 16 items, 1 language
Itemgroups: Lesion Measurements, Sum; Multiplicative Product, Post- Treatment Response, Consensus Criteria, 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

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Post- Treatment Response Week 13 (Visit 8)

- 8/18/18 - 1 form, 7 itemgroups, 31 items, 1 language
Itemgroups: X-Ray Computed Tomography | Result | Diagnostic radiologic examination | Result, Bone Marrow Biopsy, Medication, Measurable Lymphoma Disease, Non- Measurable Disease, Response, 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

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Post- Treatment Response Week 7 (Visit 6)

- 8/18/18 - 1 form, 7 itemgroups, 31 items, 1 language
Itemgroups: X-Ray Computed Tomography | Result | Diagnostic radiologic examination | Result, Bone Marrow Biopsy, Medication, Measurable Lymphoma Disease, Non- Measurable Disease, Response, 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

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Post- Treatment Response Follow- Up

- 8/18/18 - 1 form, 7 itemgroups, 29 items, 1 language
Itemgroups: Visit Week, X-Ray Computed Tomography | Result | Diagnostic radiologic examination | Result, Bone Marrow Biopsy, Measurable Lymphoma Disease, Non- Measurable Disease, Response, 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