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End of study LenaMain-Study - Trial End

- 17/03/16 - 1 modulo, 10 itemgroups, 94 elementi, 1 linguaggio

Itemgroups: End of study, Survival Status, Monthly control visit with response evaluation, Parameter of multiple myeloma, Vital signs, Laboratory:Protein electrophoresis, Laboratory:Hematology, Laboratory:serum chemistry, Quality of life, Hematotoxicity CTC

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

End of study PETAL Study NCT00554164 - End of study

- 23/11/16 - 1 modulo, 4 itemgroups, 25 elementi, 2 lingue

Itemgroups: Comorbidity, Discontinuation, Adverse event, Footer module

Positronen-Emissionstomographie-gesteuerte Therapie aggressiver Non-Hodgkin-Lymphome (PETAL-Studie) Universitätsklinikum Essen (UK Essen) EudraCT-Nummer: 2006-001641-33 NCT00554164

End of Study AMLSG 21-13 DRKS00007189 NCT02013648 Akute myeloische Leukämie (AML) - End of Study AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

- 11/02/16 - 1 modulo, 2 itemgroups, 13 elementi, 1 linguaggio

Itemgroups: End of Study, Signature

Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel(TM)) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

Studienende / Studienabbruch EudraCT 2008-004583-40 Akute myeloische Leukämie(AML) AML alle außer FAB M3 - Studienende / Studienabbruch

- 22/12/14 - 1 modulo, 3 itemgroups, 10 elementi, 2 lingue

Itemgroups: Study end, Early termination of clinical trial, Unterschrift

A randomized, multi-center phase II trial to assess the efficacy of 5-azacytidine added to standard primary therapy in elderly patients with newly diagnosed AML

End of study AML Pazopanib NCT01361334

- 11/02/16 - 1 modulo, 3 itemgroups, 31 elementi, 2 lingue

Itemgroups: End of Study, Studienabbruch: verletzte Ein-Ausschlusskrit. RQG, Studienabbruch: Unerwünschte(s) Ereignis(se) RQG

Pilot Clinical Trial of Pazopanib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or at Initial Diagnosis When no Intensive Treatment is Possible (PAZOPANIB-AML) https://clinicaltrials.gov/ct2/show/NCT01361334 Principal Investigator: PD Dr. Torsten Kessler, University Hospital Muenster, Germany

Investigational Product Discontinuation Mepolizumab HES NCT00086658 - Investigational Product Discontinuation

- 05/06/17 - 1 modulo, 1 ItemGroup, 4 elementi, 1 linguaggio

ItemGroup: Investigational Product Discontinuation

Study part: Investigational Product Discontinuation.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.

Study conclusion Mepolizumab HES NCT00086658 - Study conclusion

- 05/06/17 - 1 modulo, 1 ItemGroup, 5 elementi, 1 linguaggio

ItemGroup: STUDY CONCLUSION

Study part: Study conclusion.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.

Genetic Screening For HLA-B5701 in Patients with HIV Study Conclusion NCT00340080 - Genetic Screening For HLA-B5701 Study Conclusion NCT00340080

- 25/04/17 - 1 modulo, 1 ItemGroup, 5 elementi, 1 linguaggio

ItemGroup: Study Conclusion

NCT00340080 / VIIV-CNA106030 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Study Conclusion Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

HLA-B*5701 And Hypersensitivity To Abacavir End of Study NCT00373945

- 12/04/17 - 1 modulo, 5 itemgroups, 17 elementi, 1 linguaggio

Itemgroups: Date of Visit/Assessment, Study Conclusion, Pregnancy Information, PGx-Pharmacogenetic Research Withdrawal of Consent, Investigator Signature

A Retrospective Case-Control Study to Estimate the Sensitivity and Specificity of a Pharmacogenetic Marker (HLA-B*5701) in Subjects With and Without Hypersensitivity to Abacavir Assessment: End of Study NCT00373945 / VIIV-ABC107442 Annotated Design For Trial:abc442_lgm Protocol:ABC107442 Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus I, Phase: 4, Clinical Study ID: ABC107442, Sponsor: ViiV

10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010 - Study Conclusion

- 03/09/19 - 1 modulo, 3 itemgroups, 21 elementi, 1 linguaggio

Itemgroups: Administrative documentation, Study Conclusion, Investigator's Signature

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains the Study Conclusion and is to be used twice - at the interim analysis at/after Visit 6 and at the final analysis at the end of the study (or if the subject has been withdrawn).

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Investigational product discontinuation

- 30/03/21 - 1 modulo, 2 itemgroups, 5 elementi, 1 linguaggio

Itemgroups: Administrative Data, Investigational Product Discontinuation

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 end of study/ end of treatment. Complete this Form when the subject permanently stops the investigational product (IP). If the subject decided to withdraw consent and stop participation in the study, also complete the End of Study Form. If the subject decided to permanently stop the investigational product but will be followed for disease progression or survival per protocol, do not complete the End of Study Form until follow-up is complete.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - End of Study

- 30/03/21 - 1 modulo, 5 itemgroups, 23 elementi, 1 linguaggio

Itemgroups: Administrative Data, Pregnancy information, End of study, End of study details, Signature

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. Per protocol, subjects are to be followed until the subject completes the observation phase, the subject withdraws consent or the subject dies. Subjects who do not complete the treatment phase, should be followed until they complete the observation phase, withdraw consent or die. This form has to be filled out at the end of study/ end of treatment.

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