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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
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Blood products, blood supportive care and concomitant medication

- 8/25/21 - 1 form, 3 itemgroups, 24 items, 1 language
Itemgroups: Administrative Data,Blood Products and Blood Supportive Care Products (BLD),Concomitant Medications
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 whenever/if blood products, blood supportive care products or other concomitant medication is administered during study.

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Period 1

- 3/13/19 - 1 form, 14 itemgroups, 93 items, 2 languages
Itemgroups: Administrative data,Vital Signs Pre-Challenge,Randomisation Number,Investigational Product (Dose),Vital Signs (Dosing),Temperature (Dosing),Hematology (Dosing),Clinical Chemistry,Electrocardiogram,Peak Nasal Inspiratory Flow Rate,Total Symptom Score,Visual Analogue Scale,Nostril Secretions,Pharmacokinetics - Blood
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

The effect of intranasal capsaicin challenge model in healthy volunteers - 111611 - Period 2

- 3/13/19 - 1 form, 12 itemgroups, 87 items, 2 languages
Itemgroups: Administrative data,Investigational Product (Dose),Vital Signs (Dosing),Temperature (Dosing),Hematology (Dosing),Clinical Chemistry,Electrocardiogram,Peak Nasal Inspiratory Flow Rate,Total Symptom Score,Visual Analogue Scale,Nostril Secretions,Pharmacokinetics - Blood
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Visit 6: Eligibility Check, Laboratory Test

- 1/11/19 - 1 form, 4 itemgroups, 17 items, 1 language
Itemgroups: Administrative data,Check for Study Continuation,Elimination Criteria During The Study,Laboratory Tests - Blood
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Period 1 Day 1 (Visit 80)

- 12/21/18 - 1 form, 9 itemgroups, 49 items, 1 language
Itemgroups: Administrative data,Admission Criteria,Study Drug Administration,Laboratory Test - Hematology,Laboratory Test - Chemistry,Laboratory Test - UA / UDS / Urine HCG / Urine Chemistry,Vital Signs,Pharmacodynamic Blood Collection,Pharmacodynamic Blood Collection
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

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Follow-Up: Laboratory Tests

- 11/16/18 - 1 form, 5 itemgroups, 23 items, 1 language
Itemgroups: Administrative data,Timepoint,Hematology,Chemistry/Serum HCG,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

Estimation of Dose Proportionality of Darapladib - 107038 - Pharmacokinetics (Blood) - [Darapladib and PK]

- 11/12/18 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Administrative data,Predose
Study ID: 107038 Clinical Study ID: LPL107038 Study Title: Study to Estimate the Dose Proportionality of the Enteric-Coated Freebase Formulation of SB-480848 Patient Level Data:  Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: Tyrisa ,US Study Indication: Atherosclerosis

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