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On-Study - Palliative Treatment for Head and Neck Cancer - On-Study Form - 2267713v3.0 - Palliative Treatment for Head and Neck Cancer - On-Study Form

- 20.09.21 - 1 Formular, 9 Itemgruppen, 85 Datenelemente, 1 Sprache
Itemgruppen: CRF Header, Head & Neck: Form Administration, Head & Neck: Patient Assessment, Head & Neck: Disease Description - Initial Diagnosis of Disease, Head & Neck: Disease Description - Current Diagnosis, Head & Neck: Prior Health History - Palliative, Head & Neck: Prior Treatment - Systemic Therapy, Head & Neck: Prior Treatment - Radiation Therapy, Head & Neck: Prior Treatment - Surgery
Palliative Treatment for Head and Neck Cancer - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=20B9E4F5-9DD3-2343-E044-0003BA3F9857

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Session 2: Treatment Confirmation

- 13.12.18 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Treatment Confirmation
Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020 - Visit 1: Temperature Form

- 23.11.18 - 1 Formular, 3 Itemgruppen, 12 Datenelemente, 1 Sprache
Itemgruppen: Post-Dose Temperature, Temperature Log, Fever Screen
Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Liver Biopsy Data: Liver Infections

- 20.11.18 - 1 Formular, 3 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Liver Biopsy, J. Liver Infections
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Pancreatitis Patient Data

- 19.11.18 - 1 Formular, 8 Itemgruppen, 41 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Pancreatitis, Alcohol, Family History of Pancreatitis, Recent Trauma/Vascular Invasive Procedures or Surgery, Concomitant Medications, Symptoms of Gatrointestinal Illness Associated with Pancreatitis, Other Symptoms Associated with Pancreatitis
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 92: Vital Signs

- 16.11.18 - 1 Formular, 2 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Vital Signs
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 40: Study Drug Administration

- 16.11.18 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Study Drug Administration
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 39: Pharmacokinetic Blood Collection

- 16.11.18 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Pharmacokinetic Blood Collection
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 39: Holter Monitoring

- 16.11.18 - 1 Formular, 2 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Holter Monitoring
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 37: Predose Laboratory Tests

- 16.11.18 - 1 Formular, 3 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Timepoint, UA/Urine Chemistry
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 36: Predose - Pharmacokinetic Blood Collection

- 16.11.18 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Pharmacokinetic Blood Collection
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Day 36: Holter Monitoring

- 16.11.18 - 1 Formular, 2 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Administrative data, Holter Monitoring
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

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