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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Local Lab Assessments

- 16-03-21 - 1 Formulier, 3 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Laboratory Information, Local Lab Assessments
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 first and last weekly visits during treatment cycles (week 1 and week 4), cycle observation visits, possible unscheduled and withdrawal visits.

Oral GW786034 treatment for ovarian cancer NCT00281632 - Screening

- 15-03-21 - 1 Formulier, 24 Itemgroepen, 129 Data-elementen, 2 Talen
Itemgroepen: Header, Eligibility Question, Demography, Physical examination, Disease Characteristics, Metastatic Disease Site, local laboratory, Residual toxicities related to previous therapy for cancer, Residual toxicities, Cancer related current medical conditions, Medical Conditions, non-cancer related medical conditions, Medical Conditions, Prior anti-cancer therapy, Prior anti-cancer therapy - medication, Prior anti-cancer therapy - radiotherapy, Vital signs, ECOG Performance Status Scale, 12 LEAD ECG, 12-lead ECG Abnormalities, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Electronically transferred laboratory data
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Hepatitis - Local Lab

- 09-02-21 - 1 Formulier, 3 Itemgroepen, 8 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Hepatitis - Local Laboratory, Hepatitis - Local, Laboratory Procedures
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.

Collaborative Research Center | Transregio 240 (Sonderforschungsbereich Transregio 240) - Study specific blood sample and biobank (Studienspezifische Blutentnahme und Biobank)

- 01-10-20 - 1 Formulier, 8 Itemgroepen, 40 Data-elementen, 2 Talen
Itemgroepen: Administrative Data, Date, time and blood pressure at blood sample taking, Flow cytometry and aggregometry, Biobank, Biobank: EDTA wholeblood, Biobank: EDTA Plasma, Biobank: Citrat Plasma, Biobank: Serum
A central patient cohort within the interdisciplinary Collaborative Research Center / Transregio 240 aims to examine the role and function of platelets in different vascular diseases. For all patients enrolled in a CRC/TR240 cohorts (routine) blood markers are collected from the first blood draw.

Collaborative Research Center | Transregio 240 (Sonderforschungsbereich Transregio 240) - Laboratory (Labor)

- 01-10-20 - 1 Formulier, 22 Itemgroepen, 95 Data-elementen, 1 Taal
Itemgroepen: Patient-ID, Biological markers: Inflammation parameters, Cardiac biomarkers: Troponin T, Cardiac biomarkers: NT-proBNP, Renal function marker: serum creatinine, Renal function marker: urine creatinine, Renal function marker: Urea, Lipids: Cholesterol, Lipids: High density Lipoprotein, Lipids: Low-density Lipoprotein, Lipids: triglycerides, Blood glucose (Spontaneous), Blood glucose (Fasting), Blood glucose: HbA1c, Blood glucose: fasting Insulin, Blood glucose (oral glucose tolerance test), Blood cell count: hematocrit, Blood cell count: hemoglobin, Blood cell count: leukocytes, Blood cell count: thrombocytes, Platelet Isolates, Multiplate Analysis
A central patient cohort within the interdisciplinary Collaborative Research Center / Transregio 240 aims to examine the role and function of platelets in different vascular diseases. For all patients enrolled in a CRC/TR240 cohorts (routine) blood markers are collected from the first blood draw.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Local Laboratory

- 20-07-20 - 1 Formulier, 3 Itemgroepen, 21 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Clinical Chemistry, Haematology
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the Local Laboratory for clinical chemistry and haematology which have to be filled in once for Screening, Day-1, Week 1-3, the Follow-up visit and as often as necessary in logs and repeats. Week 3 assessments can be used as Follow-up assessments for subjects who have completed the 24 hour PK blood draw at the Week 3 visit and are proceeding into the continuing study EGF111767.

Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160 - Laboratory Tests

- 10-11-19 - 1 Formulier, 3 Itemgroepen, 13 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Laboratory Tests, Repeat Laboratory Tests
Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders The purpose of this form is to record the results of the subject's laboratory tests and should be filled out at Visit 1, 6 (liver tests only) , 8, EW, Day 7 Follow Up (unless Day 7 FU follows Early Withdrawal Visit) and Day 14 Follow Up (only if abnormal at previous Visit). Additionally, this form is used to record unscheduled (repeat) measurements.

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Electronically Transferred Lab Data

- 15-09-19 - 1 Formulier, 1 Itemgroep, 4 Data-elementen, 1 Taal
Itemgroep: Laboratory Procedures
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Electronically Transferred Lab Data - Follow-up

- 29-08-19 - 1 Formulier, 1 Itemgroep, 9 Data-elementen, 1 Taal
Itemgroep: Laboratory Procedures
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Electronically Transferred Lab Data - Day -1

- 28-08-19 - 1 Formulier, 1 Itemgroep, 9 Data-elementen, 1 Taal
Itemgroep: Laboratory Procedures
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Electronically Transferred Lab Data

- 28-08-19 - 1 Formulier, 1 Itemgroep, 6 Data-elementen, 1 Taal
Itemgroep: Laboratory Procedures
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Laboratory Tests

- 16-08-19 - 1 Formulier, 5 Itemgroepen, 31 Data-elementen, 1 Taal
Itemgroepen: Administrative documentation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Blood Chemical Analysis, Laboratory Procedures, Urinalysis, Laboratory Procedures, Correlative Study, Tissue specimen
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

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