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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Visit 4 iabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/19/22 - 1 form, 11 itemgroups, 49 items, 1 language
Itemgroups: Date of Visit,Physical Examination,Orthostatic vital signs,12 Lead ECG,Weight,Waist and Hip Circumference,Pregnancy Test,Randomization,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 Mellitus Visit 4

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

- 2/19/22 - 1 form, 10 itemgroups, 45 items, 1 language
Itemgroups: 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

- 2/19/22 - 1 form, 4 itemgroups, 14 items, 1 language
Itemgroups: 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

Visit 8 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/19/22 - 1 form, 8 itemgroups, 27 items, 1 language
Itemgroups: Date of Visit,Orthostatic Vital Signs,ECG: 12 Lead ECG 1,Weight,Waist and Hip Circumference,Pregnancy Test,Meal Data,Blood Sample
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 Mellitus Visit 8

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

- 2/18/22 - 1 form, 18 itemgroups, 97 items, 1 language
Itemgroups: 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

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

- 2/18/22 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: 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

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

- 2/18/22 - 1 form, 10 itemgroups, 45 items, 1 language
Itemgroups: 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 3 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/17/22 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: 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 3

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

- 2/16/22 - 1 form, 4 itemgroups, 13 items, 1 language
Itemgroups: 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

- 11/26/21 - 1 form, 4 itemgroups, 9 items, 1 language
Itemgroups: 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

- 11/26/21 - 1 form, 3 itemgroups, 9 items, 1 language
Itemgroups: 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

- 11/26/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: 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.

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