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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410) - Screening - Prior an Concomitant Medication; Telephone Randomisation

- 18.04.21 - 1 Formular, 4 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Prior and Concomitant Medication, Prior and Concomitant Medication , Telephone Randomisation
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Anal Cancer NCT00324415 Treatment - AMC-045 Concomitant Medication Form (MED) - 2936871v1.0 - AMC-045 Concomitant Medication Form (MED)

- 13.04.21 - 1 Formular, 2 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: Concomitant Medications, Comments
AMC-045 Concomitant Medication Form (MED) Cisplatin, Fluorouracil, Cetuximab, and Radiation Therapy in Treating Patients With HIV and Stage I, Stage II, or Stage III Anal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=72844558-61F6-0B0B-E040-BB89AD4314AD

Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma NCT00992758 - Infection Summary; Concomitant Medications and Transfusions; Adverse Experiences

- 29.03.21 - 1 Formular, 9 Itemgruppen, 48 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Infection Summary, Infection Summary - Culture information, Infection Summary - Anti-infective, Infection Summary - Anti-infective , Concomitant Medications and Transfusions, Adverse Experiences, Adverse Experiences, Adverse Experiences - Investigator Signature
Study ID: 104512 Clinical Study ID: 104512 Study Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody for Patients With Previously Treated Non Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992758 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Iodine-131 Anti-B1 Antibody Trade Name: Tositumomab Study Indication: Lymphoma, Non-Hodgkin

End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 15.03.21 - 1 Formular, 4 Itemgruppen, 32 Datenelemente, 2 Sprachen
Itemgruppen: Medications, Adverse Events, Transfusion history during the entry study, Conclusion of the Study and Termination
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

End form: Other diseases and therapies except tumors VTETumor02 Prophylactic Treatment of Thromboembolism with Enoxaparin EudraCT number: 2007-002036-28 - Other diseases and therapies except tumors

- 15.03.21 - 1 Formular, 1 Itemgruppe, 9 Datenelemente, 1 Sprache
Itemgruppe: other disease; treatment
Study documentation part: Other diseases and therapies except tumors, VTETumor02. This is a prospective, randomized, controlled, unicentric, open study on prophylactic treatment of thromboembolism with Enoxaparin in non-surgical oncology patients under systemic antineoplastic therapy. Principal Investigator Prof. Dr. Max E. Scheulen, Clinic and Polyclinic for Internal medicine (Tumor research), University Hospital of Essen, Germany. EudraCT number: 2007-002036-28, Version 0.6 vom 06.08.09.

60 DAYS POST-TREATMENT CONCOMITANT MEDICATIONS Roche H0650g Breast Cancer - 60 DAYS POST-TREATMENT CONCOMITANT MEDICATIONS

- 15.03.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: CONCOMITANT MEDICATIONS
Study part: 60 Days Post- Treatment Concomitant medications. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

CONCOMITANT MEDICATIONS Roche H0650g Breast Cancer - CONCOMITANT MEDICATIONS

- 15.03.21 - 1 Formular, 1 Itemgruppe, 11 Datenelemente, 1 Sprache
Itemgruppe: CONCOMITANT MEDICATIONS
Study part: Concomitant medications. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

PREVIOUS/ CONCOMITANT MEDICATIONS Roche H0650g Breast Cancer - PREVIOUS/ CONCOMITANT MEDICATIONS

- 15.03.21 - 1 Formular, 1 Itemgruppe, 10 Datenelemente, 1 Sprache
Itemgruppe: CONCOMITANT MEDICATIONS
Study part: Previous/ Concomitant medications. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

Iodine-131 Anti-B1 Antibody for Non Hodgkin’s Lymphomas NCT00996593 - Concomitant Medications and Transfusions and Adverse Experiences

- 15.03.21 - 1 Formular, 5 Itemgruppen, 27 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Concomitant Medications and Transfusions, Adverse event, Adverse event, Investigator Signature
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

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Visit 1; Visit 2; Visit 3; Visit 4; Visit 5; Visit 6; Visit 7; Visit 8; Visit Maintenance 1 +2; Early Withdrawal; Follow up; Optional Visit; Unscheduled - PR/Conmeds; SOOS; Vitals

- 15.03.21 - 1 Formular, 8 Itemgruppen, 54 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Prior/ Current Concomitant Medications, Prior/ current non-drug therapies, Non-drug therapies, Sudden Onset of Sleep Questionnaire, Vital Signs - Semi supine , Vital Signs - Standing , Physical Exam
Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532) - Baseline - PR/ Conmeds; Pregnancy; Sudden Onset of Sleep Questionnaire

- 15.03.21 - 1 Formular, 6 Itemgruppen, 39 Datenelemente, 1 Sprache
Itemgruppen: Administrative, Prior/ Current Concomitant Medications, Prior/ current non-drug therapies, Non-drug therapies, Pregnancy, Sudden Onset of Sleep Questionnaire
Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Efficacy and Safety of Single Dose Intranasal GSK1004723 in an Allergen Challenge Chamber NCT00824356 - Logs and Repeats - Concomitant Medications; 12-Lead ECG; Vital Signs; Laboratory; Urinalysis; Pulmonary Function Tests; Nasal Airflow Resistance; Nasal Inspection

- 11.03.21 - 1 Formular, 13 Itemgruppen, 80 Datenelemente, 1 Sprache
Itemgruppen: Concomitant Medication, 12-Lead ECG/ Holter/ Telemetry ECG, ECG Abnormalities, Vital Signs, Local Laboratory, Local Laboratory - Haematology , Local Laboratory - Clinical Chemistry, Urinalysis - Local, Urinalysis - Local: Dipstick Details, Urinalysis - Local: Microscopy Details, Pulmonary Function Tests, Nasal Airflow Resistance, Nasal Inspection
Study ID: 110159 Clinical Study ID: 110159 Study Title: A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00824356 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, GSK1004723 (200mg), GSK1004723 (1000mg) Study Indication: Allergic Rhinitis

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