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Liver imaging GSK study Chronic Coronary Heart Disease NCT00799903

- 6/17/20 - 1 form, 11 itemgroups, 60 items, 1 language
Itemgroups: 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

- 12/6/18 - 1 form, 14 itemgroups, 157 items, 1 language
Itemgroups: 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

- 1/11/18 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: 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

- 1/11/18 - 1 form, 1 itemgroup, 6 items, 1 language
Itemgroup: 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)

Investigational product (Liver) GSK study Chronic Coronary Heart Disease NCT00799903

- 1/4/18 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Liver event during treatment period, Liver event after treatment period
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: Investigational product (Liver)

Medical conditions (Liver) GSK study Chronic Coronary Heart Disease NCT00799903

- 1/4/18 - 1 form, 4 itemgroups, 29 items, 1 language
Itemgroups: Liver disease medical conditions, Drug related liver disease problems, Other liver disease conditions, Other medical conditions
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: Medical conditions (Liver)

GI conditions of special interest GSK study Chronic Coronary Heart Disease NCT00799903

- 1/11/18 - 1 form, 3 itemgroups, 22 items, 1 language
Itemgroups: GI conditions of special interest, History of adenomatous polyps, Family history of intestinal cancer or adenomatous polyps
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: GI conditions of special interest Report form

Alcohol intake (liver alcohol) GSK study Chronic Coronary Heart Disease NCT00799903

- 1/2/18 - 1 form, 1 itemgroup, 3 items, 1 language
Itemgroup: Alcohol intake (liver alcohol)
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: Alcohol intake (liver alcohol)

GI procedures Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

- 1/1/18 - 1 form, 2 itemgroups, 17 items, 1 language
Itemgroups: GI Procedures post-randomization, GI procedures entry
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: GI procedured report form - Repeating form (Scheduled visits)

Eligibility Portopulmonary Hypertension NCT01028651

- 8/29/18 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01028651

Eligibility Portal Hypertension NCT01032941

- 9/20/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
The Effect of Probiotics (VSL) on Portal Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01032941

Eligibility Portal Hypertension NCT00737594

- 9/20/21 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00737594

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