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Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

- 17-06-20 - 1 Formulier, 11 Itemgroepen, 60 Data-elementen, 1 Taal

Itemgroepen: 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: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Liver imaging - Repeating form (Unscheduled/Dynamic visit)

Liver biopsy GSK study Chronic Coronary Heart Disease NCT00799903

- 06-12-18 - 1 Formulier, 14 Itemgroepen, 157 Data-elementen, 1 Taal

Itemgroepen: Date of liver biopsy, Liver Biopsy size, Liver Biopsy Final Diagnosis, Liver Architecture, Description of Liver Cells or Hepatocytes, Liver Cell or Hepatocyte Inclusions or Vacuoles, Hepatocyte or Liver Cell Nuclear Abnormalities, Liver or Lobular Infiltrates, Portal Tract Inflammation, Bile Ducts, Portal Veins, Liver Infections, Liver: Parasites or Ova, Histologic Staining or Additional Studies Obtained

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Liver biopsy - Repeating form (Unscheduled/Dynamic visit)

Liver events GSK study Chronic Coronary Heart Disease NCT00799903

- 11-01-18 - 1 Formulier, 2 Itemgroepen, 13 Data-elementen, 1 Taal

Itemgroepen: liver chemistry results, Liver events

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Liver events

Pharmacokinetics Liver GSK study Chronic Coronary Heart Disease NCT00799903

- 11-01-18 - 1 Formulier, 1 Itemgroep, 6 Data-elementen, 1 Taal

Itemgroep: Pharmacokinetics Liver

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Pharmacokinetics (Liver PK)

laboratory analysis (resurvey) SHIP-START-0 liver function - liver function

- 03-07-21 - 1 Formulier, 1 Itemgroep, 29 Data-elementen, 2 Talen

Itemgroep: liver function

liver function form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIP0.LABRE.RE_BLUT.RE_LIVR. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

laboratory analysis (resurvey) SHIP-START-1 liver function - liver function

- 03-07-21 - 1 Formulier, 1 Itemgroep, 19 Data-elementen, 2 Talen

Itemgroep: liver function

liver function form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIP1.LABRE.RE_BLUT.RE_LIVR. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

medical examination SHIP-START-3 echo liver

- 03-07-21 - 1 Formulier, 1 Itemgroep, 20 Data-elementen, 2 Talen

Itemgroep: echo liver

echo liver form of SHIP Study (Study of Health in Pomerania), conducted by the University Medicine of Greifswald. SHIP unique domain name SHIP.SHIP3.MEX.ULTRASOU.LIVERUS. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617 The English version of this form is under development.

laboratory analysis (resurvey) SHIP-Trend-0 liver function

- 07-11-17 - 1 Formulier, 1 Itemgroep, 21 Data-elementen, 2 Talen

Itemgroep: liver function

liver function form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.LABRE.RE_BLUT.RE_LIVR. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

laboratory analysis SHIP-Trend-1 liver function

- 30-10-17 - 1 Formulier, 1 Itemgroep, 12 Data-elementen, 2 Talen

Itemgroep: liver function

liver function form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name TREND.TREND1.LAB.BLUT.LIVR. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

MRT SHIP-Trend-0 MRT-findings: liver

- 08-12-17 - 1 Formulier, 1 Itemgroep, 28 Data-elementen, 2 Talen

Itemgroep: MRT-findings: liver

MRT-findings: liver form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.MRT.MRTBEF.MRTLEBER. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

reading of ultrasound examinations SHIP-Trend-0 Leber-Befunde Protokoll

- 06-12-17 - 1 Formulier, 1 Itemgroep, 6 Data-elementen, 1 Taal

Itemgroep: Leber-Befunde Protokoll

Leber-Befunde Protokoll form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.RUE.READLIVER.LIVERREAD. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

reading of ultrasound examinations SHIP-Trend-0 Leber-Befunde Messwerte

- 28-11-17 - 1 Formulier, 1 Itemgroep, 17 Data-elementen, 2 Talen

Itemgroep: Leber-Befunde Messwerte

Leber-Befunde Messwerte form of SHIP Study (Study of Health in Pomerania), conducted by the University of Greifswald. SHIP unique domain name SHIP.SHIPTrend0.RUE.READLIVER.LIVERREADDATA. ODM derived from https://www.fvcm.med.uni-greifswald.de/dd_service/data_use_explore.php. Further information: http://www2.medizin.uni-greifswald.de/cm/fv/ship.html. Publication granted by Prof. Völzke. Reference: Völzke H, et al. Cohort profile: the study of health in Pomerania. Int J Epidemiol. 2011;40(2):294-307. PMID: 20167617

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