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  1. 1. Klinische studie
  2. 2. Routinedocumentatie
  3. 3. Register-/kohortstudies
  4. 4. Kwaliteitswaarborging
  5. 5. Datastandaard
  6. 6. Patiëntenvragenlijst
  7. 7. Medisch vakgebied
    1. 7.1. Anesthesie
    1. 7.2. Dermatologie
    1. 7.3. HNO
    1. 7.4. Geriatrie
    1. 7.5. Gynaecologie/Ostetrie
    1. 7.6. Interne geneeskunde
      1. Hematologie
      1. Epidemiologie
      1. Cardiologie/Angiologie
      1. Pneumologie
      1. Gastro-enterologie
      1. Nefrologie
      1. Endocrinologie/Metabolisme
      1. Rheumatologie
    1. 7.7. Neurologie
    1. 7.8. Oogheelkunde
    1. 7.9. Palliatieve zorg
    1. 7.10. Pathologie/Forensische Geneeskunde
    1. 7.11. Kindergeneeskunde
    1. 7.12. Psychiatrie/Psychosomatisch
    1. 7.13. Radiologie
    1. 7.14. Chirurgie
      1. Algemene/maag-darm-chirurgie
      1. Neurochirurgie
      1. Plastische chirurgie
      1. Cardiothoracale chirurgie
      1. Traumachirurgie/Orthopedie
      1. Vaatchirurgie
    1. 7.15. Urologie
    1. 7.16. Tandheelkunde/MKG
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Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556 - Cycle 1 Day 21 - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Urinalysis microscopy results; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

- 30-10-19 - 1 Formulaire, 19 Groupes Item, 82 Eléments de données, 1 Langue
Groupes Item: Administrative, Visit Date, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Results, 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, PK Sampling - Plasma Samples, 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

- 10-03-19 - 1 Formulaire, 23 Groupes Item, 109 Eléments de données, 1 Langue
Groupes Item: 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 + 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

- 10-03-19 - 1 Formulaire, 23 Groupes Item, 107 Eléments de données, 1 Langue
Groupes Item: 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 - Unscheduled - Physical Examination; Vital Signs; 12-Lead ECG; Hematology; Clinical Chemistry, Coagulation and Electrolytes; Urinalysis; Serum beta-hCG Pregnancy Test; Radiographic Assessment; Disease Marker Assessment

- 05-03-19 - 1 Formulaire, 19 Groupes Item, 95 Eléments de données, 1 Langue
Groupes Item: Administrative, 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
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 1 Day 1 (Pre Dose) - Eligibility Summary; Physical Examination; Vital Signs; Serum beta-hCG Pregnancy Test; PK Sampling - Plasma Samples; SRT501 Administration

- 03-03-19 - 1 Formulaire, 9 Groupes Item, 36 Eléments de données, 1 Langue
Groupes Item: Administrative, Visit Date, Eligibility Summary , Was a physical examination performed?, Physical Examination, Vital Signs, Serum beta-hCG Pregnancy Test, PK Sampling - Plasma Samples, SRT501 Administration
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

- 01-03-19 - 1 Formulaire, 23 Groupes Item, 109 Eléments de données, 1 Langue
Groupes Item: 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 - Screening - 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

- 01-03-19 - 1 Formulaire, 19 Groupes Item, 97 Eléments de données, 1 Langue
Groupes Item: Administrative, Was a physical examination performed?, Physical Examination, Vital Signs, 12-Lead ECG, ECG Results, 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
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

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment

- 18-11-21 - 9 Formulaires, 1 Groupe Item, 3 Eléments de données, 1 Langue
Groupe Item: Subject details
Study documentation part: On- Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

On-Treatment 1

15 Groupes Item 84 Eléments de données

On-Treatment 2

13 Groupes Item 62 Eléments de données

On-Treatment 4

12 Groupes Item 62 Eléments de données

On-Treatment 6

12 Groupes Item 62 Eléments de données

On-Treatment 7

13 Groupes Item 67 Eléments de données

On-Treatment 8

13 Groupes Item 67 Eléments de données

Pregnancy tests LenaMain-Study - Additional Pregnancy Test

- 17-03-16 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Pregnancy test
A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma. Protocol-Code: RV-MM-PI-280 EudraCT-Number: 2007-003945-33 Author: Claus Schreiber Review: Gerd Felder Approval of CRF: Prof. Dr. med. G. Kobbe (LKP) Release for MDM: Prof. Gattermann, Düsseldorf (26.1.2016) Principal Investigator „LenaMain“-Studie: Prof. Roland Fenk, Düsseldorf Coordinating center for clinical trial Medical faculty of University Hospital Heinrich-Heine-University Scientific Director: Herr Dr. J. Grebe Moorenstrasse 5 40225 Düsseldorf Tel.: +49 (0) 211-81-19701 Fax: +49 (0) 211-81-19702

Urine Pregnancy Test Prompt Safety follow-up visit Mepolizumab HES NCT00086658 - Urine Pregnancy Test Prompt Safety follow-up visit

- 15-07-17 - 1 Formulaire, 1 Groupe Item, 2 Eléments de données, 1 Langue
Groupe Item: Urine Pregnancy Test
Study part: Urine Pregnancy Test Prompt Safety follow-up 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.

Serum Pregnancy Test Prompt Week 38 Mepolizumab HES NCT00086658 - Serum Pregnancy Test Prompt Week 38

- 15-07-17 - 1 Formulaire, 1 Groupe Item, 2 Eléments de données, 1 Langue
Groupe Item: Serum Pregnancy Test
Study part: Serum Pregnancy Test Prompt 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.

Urine Pregnancy Test Prompt Week 32 Mepolizumab HES NCT00086658 - Urine Pregnancy Test Prompt Week 32

- 12-07-17 - 1 Formulaire, 1 Groupe Item, 2 Eléments de données, 1 Langue
Groupe Item: Urine Pregnancy Test
Study part: Urine Pregnancy Test Prompt Week 32. 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.

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