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

Visit 9 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 19.02.22 - 1 Formulaire, 10 Groupes Item, 45 Eléments de données, 1 Langue

Groupes Item: Date of Visit, Physical Examination, Orthostatic vital signs, 12 Lead ECG, Weight, Waist and Hip Circumference, Pregnancy Test, EQ-5D, ADDQol, Diab-MedSat

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Visit 9

Visit 3 (Washout) Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 19.02.22 - 1 Formulaire, 4 Groupes Item, 14 Eléments de données, 1 Langue

Groupes Item: Date of Visit, Orthostatic Vital Signs, 12 Lead ECG, Weight

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Visit 3

Screening Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 18.02.22 - 1 Formulaire, 18 Groupes Item, 97 Eléments de données, 1 Langue

Groupes Item: Cover Page, Informed Consent, Inclusion Criteria, Exclusion Criteria, Demographics, Primary Diagnosis, Subject Characteristics, Date of Visit, Tobacco History, Alcohol History, Urinary Tract Infection History, Genital Infection History, Physical Examination, Orthostatic vital signs, 12 Lead ECG 1, Height and Weight, Previous Diabetes Medication Use, Pregnancy Test

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Screening

Early Discontinuation Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 18.02.22 - 1 Formulaire, 10 Groupes Item, 45 Eléments de données, 1 Langue

Groupes Item: Date of Visit, Physical Examination, Orthostatic vital signs, 12 Lead ECG 1, Weight, Waist and Hip Circumference, Pregnancy Test, EQ-5D, ADDQol, Diab-MedSat

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Early Discontinuation

Visit 2 (Washout) Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 18.02.22 - 1 Formulaire, 3 Groupes Item, 11 Eléments de données, 1 Langue

Groupes Item: Date of Visit, Orthostatic Vital Signs, Weight

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Visit 2

Visit 10 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 16.02.22 - 1 Formulaire, 4 Groupes Item, 13 Eléments de données, 1 Langue

Groupes Item: Date of Visit, Orthostatic Vital Signs, Weight, Waist and Hip Circumference

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Electronically transferred lab data

- 26.11.21 - 1 Formulaire, 4 Groupes Item, 9 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Blood sample, Neuro Antibody panel, Prognostic factors

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 is for documentation of electronically transferred lab data and is used for screening, cycle 1 weeks 1-4 and observation, cycle 2 weeks 1-4 and observation and on a potential withdrawal visit, as well as any unscheduled lab data available.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - PK Blood Sample

- 26.11.21 - 1 Formulaire, 3 Groupes Item, 9 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Dosing date and time, PK Blood Sample

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. Depending on which items, this form has to be filled out at the Cycle 1 week 1, 2, 3 and 4 visits, Cycle 2 week 1, 2, 3 and 4 visits, Cycle 1 and 2 observation visits and unscheduled visits.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Vital Signs

- 26.11.21 - 1 Formulaire, 2 Groupes Item, 13 Eléments de données, 1 Langue

Groupes Item: Administrative Data, Vital Signs

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 Screening Visit, the Cycle 1 week 1, 2, 3 and 4 visits, Cycle 2 week 1, 2, 3 and 4 visits and for unscheduled visits. Note: Not all items are required for all of these visits.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Liver imaging

- 26.11.21 - 1 Formulaire, 11 Groupes Item, 61 Eléments de données, 1 Langue

Groupes Item: Date of hepatic or liver imaging test, method used for imaging test, images technically adequate, liver size, liver texture, diffuse and/or geographic fatty infiltrate of the liver, Ascites present, Focal Hepatic Lesions characterisable, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities

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. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver imaging is performed (in case of a liver event).