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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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Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis - BCOND

- 3/28/24 - 352 forms, 1 itemgroup, 17 items, 1 language
Itemgroup: CDB
The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis. The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC). As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

ECG1

1 itemgroup 14 items

BIBF

1 itemgroup 32 items

BM1

1 itemgroup 21 items

ABG

1 itemgroup 18 items

BM1

1 itemgroup 21 items

AE

1 itemgroup 44 items

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.

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