Résultats de recherche - Portail des modèles médicaux de données (portail MDM)

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Liver Biopsy

- 02.01.19 - 1 Formulaire, 4 Groupes Item, 31 Eléments de données, 1 Langue

Groupes Item: Administrative data, Liver Biopsy pt 1, Liver Biopsy pt 2, Liver Biopsy pt 3

Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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

Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138 - Liver Event Details; Global Assessment of Change (Asthma Symptoms And Rescue Medication Use), Medical Problems/ Medications taken diary, Medications taken diary, Unscheduled Asthma Healthcare Contacts

- 24.11.18 - 1 Formulaire, 14 Groupes Item, 116 Eléments de données, 1 Langue

Groupes Item: Liver events, Investigational Product (Liver), Alcohol intake at onset of liver event , Medical conditions at onset of liver event , Drug related liver disease , Other Liver Disease Conditions , Other medical conditions , Pharmacokinetics (Liver) , Liver imaging , Liver biopsy , Global Assessment of Change (Asthma Symptoms And Rescue Medication Use), Medical Problems/ Medications taken diary, Medications taken diary, Unscheduled Asthma Healthcare Contacts

Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Various Adverse Events: Hypoglycemia, Injection Site Reaction, Pancreatitis, Thyroid Nodes

- 02.01.19 - 1 Formulaire, 37 Groupes Item, 183 Eléments de données, 1 Langue

Groupes Item: Administrative data, (Serious) Hypoglycaemic Events, Serious Adverse Events, Injection Site Reaction, Pancreatitis, Symptoms of Gastrointestinal Illness Associated with Pancreatitis, Pain in the Epigastrium, Pain in the Periumbical Region, Pain in the Right Upper Quadrant, Pain in the Left Upper Quadrant, Pain in the Left Lower Quadrant, Pain in the Right Lower Quadrant, Pain in the Right Flank, Pain in the Left Flank, Pain in the Back, Other Symptoms, Nausea, Vomiting, Fever, Biochemistry, Alkaline phosphatase, Total bilirubin, Direct bilirubin, Creatinine, Other lab test, Diagnostic Studies - Pancreatitis, Abdominal CT Scan, MRI, New Thyroid Nodules, Bidimensional Measurement, Thyroid Nodules AE Details, Thyroid function tests, Free T4, T4, TSH, Free T3, T3 Uptake

Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 15, Additional Vaccination) - Check for Study Continuation; General medical history/ Physical examination; Laboratory Tests; Vaccine Administration; Solicited Adverse Events - Local and General Symptoms; Unsolicited Adverse Events

- 15.04.19 - 1 Formulaire, 10 Groupes Item, 89 Eléments de données, 1 Langue

Groupes Item: Administration, Check for Study Continuation , General Medical History / Physical Examination, Medical Condition, HCG Urine Pregnancy Test, Vaccine Administration, Vaccine Administration, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms, Unsolicited Adverse Events

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 14, Additional Vaccination) - Check for Study Continuation; General medical history/ Physical examination; Laboratory Tests; Vaccine Administration; Solicited Adverse Events - Local and General Symptoms; Unsolicited Adverse Events

- 11.04.19 - 1 Formulaire, 10 Groupes Item, 89 Eléments de données, 1 Langue

Groupes Item: Administration, Check for Study Continuation , General Medical History / Physical Examination, Medical Condition, HCG Urine Pregnancy Test, Vaccine Administration, Vaccine Administration, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms, Unsolicited Adverse Events

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 13, Additional Vaccination) - General medical history/ Physical examination; Laboratory Tests; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

- 11.04.19 - 1 Formulaire, 10 Groupes Item, 85 Eléments de données, 1 Langue

Groupes Item: Administration, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, HCG Urine Pregnancy Test, Vaccine Administration, Vaccine Administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Visit 1 - Demographics; General Medical History; Laboratory Tests; Baseline Assessment; General Symptoms Observed Just Before Injection

- 15.03.19 - 1 Formulaire, 10 Groupes Item, 27 Eléments de données, 1 Langue

Groupes Item: Administration, Demographics, Eligibility, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, Baseline Temperature, Baseline Assessment - General Symptoms, General Symptoms Observed Just Before Injection, General Symptoms Observed Just Before Injection

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Visit 4 Dose 2 - Laboratory Tests; Baseline Temperature; Baseline Assessment; Vaccine Administration; Solicited Adverse Experiences - Local Symptoms and General Symptoms

- 15.03.19 - 1 Formulaire, 12 Groupes Item, 57 Eléments de données, 1 Langue

Groupes Item: Administrative, Laboratory Tests, Baseline Temperature, Baseline Assessment- General Symptoms, General Symptoms Observed Just Before Injection, General Symptoms Observed Just Before Injection , Vaccine Administration, Solicited Adverse Experiences - Local Symptoms, Local Symptoms, Solicited Adverse Experiences - General Symptoms, General Symptoms - Only for children from 1 to 5 years old, General Symptoms - Only for children from 6 to 11 years old

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Visit 1 Dose 1 - Vaccine Administration; Solicited Adverse Experiences - Local Symptoms and General Symptoms

- 15.03.19 - 1 Formulaire, 6 Groupes Item, 47 Eléments de données, 1 Langue

Groupes Item: Vaccine Administration, Solicited Adverse Experiences - Local Symptoms, Local Symptoms, Solicited Adverse Experiences - General Symptoms, General Symptoms - Only for children from 1 to 5 years old, General Symptoms - Only for children from 6 to 11 years old

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Visit 6 Booster Dose Diary Card - Local Symptoms Biologicals HepA/HepB vaccine 208127/125

- 15.10.17 - 1 Formulaire, 5 Groupes Item, 16 Eléments de données, 1 Langue

Groupes Item: Header, Redness, Swelling, Soreness, Other Local Symptoms

Visit 6 Booster Dose Diary Card - Local Symptoms Biologicals HepA/HepB vaccine 208127/125 form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. 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: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Visit 4 Dose 2 Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125

- 15.10.17 - 1 Formulaire, 8 Groupes Item, 35 Eléments de données, 1 Langue

Groupes Item: Header, Temperature, Headache, Malaise, Fatigue, Nausea, Vomiting, Other General Symptoms

Visit 4 Dose 2 Diary Card - General Symptoms form Study ID: 208127/125 Clinical Study ID: 208127/125 (Ext-HAB-038 Month 90) Study Title: A double-blind, randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' combined hepatitis A / hepatitis B vaccine in healthy children between 6 and 15 years of age. 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: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Visit 6 Booster Dose Diary Card - General Symptoms Biologicals HepA/HepB vaccine 208127/125