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Endpoint Hospitalisation for heart failure GSK study Chronic Coronary Heart Disease NCT00799903

- 9/20/21 - 1 form, 3 itemgroups, 43 items, 1 language
Itemgroups: Investigator section, CEC Section, CEC Status
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: Endpoint Hospitalisation for heart failure - Repeating form (Scheduled visits)

Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Clinical Study ID: AR1104574 - SAE Complementary Report

- 8/13/18 - 1 form, 2 itemgroups, 9 items, 1 language
Itemgroups: Administrative Data, Serious advert event
Study ID: 104574 Clinical Study ID: AR1104574 Study Title: A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thromboembolism

Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Clinical Study ID: AR1104574 - Adverse Event Report

- 8/13/18 - 1 form, 2 itemgroups, 16 items, 1 language
Itemgroups: Administrative Data, Adverse event
Study ID: 104574 Clinical Study ID: AR1104574 Study Title: A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thromboembolism

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

Endpoint Hospitalisation for unstable angina GSK study Chronic Coronary Heart Disease NCT00799903

- 1/9/18 - 1 form, 3 itemgroups, 40 items, 1 language
Itemgroups: Investigator section, CEC Section, CEC Status
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: Endpoint Hospitalisation for unstable angina - Repeating form (Scheduled visits)

Endpoint revascularisation GSK study Chronic Coronary Heart Disease NCT00799903

- 1/5/18 - 1 form, 3 itemgroups, 52 items, 1 language
Itemgroups: Coronary revascularisation, Urgent coronary revascularisation for myocardial ischemia, CEC Status
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: Endpoint revascularisation - Repeating form (Scheduled visits)

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)

Endpoint Stroke/TIA GSK study Chronic Coronary Heart Disease NCT00799903

- 1/4/18 - 1 form, 3 itemgroups, 55 items, 1 language
Itemgroups: Investigator Section, CEC Section, CEC STATUS
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: Endpoint Stroke/TIA - Repeating form (Scheduled visits)

Other endpoints GSK study Chronic Coronary Heart Disease NCT00799903

- 1/3/18 - 1 form, 2 itemgroups, 26 items, 1 language
Itemgroups: Other endpoints, CEC Status
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: Other endpoints - Repeating form (Scheduled visits)

Endpoint Myocardial infarction GSK study Chronic Coronary Heart Disease NCT00799903

- 1/3/18 - 1 form, 3 itemgroups, 48 items, 1 language
Itemgroups: Investigator Section, CEC Section, CEC STATUS
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: Endpoint Myocardial infarction - Repeating form (Scheduled visits)

Endpoint death GSK study Chronic Coronary Heart Disease NCT00799903

- 1/3/18 - 1 form, 3 itemgroups, 35 items, 1 language
Itemgroups: Investigator section, CEC Section, CEC Status
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: Endpoint death

Serious adverse events Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

- 12/28/17 - 1 form, 18 itemgroups, 126 items, 1 language
Itemgroups: SAE possible study endpoint, SAE to be adjudicated, SAE as non-adjudicated endpoint, Occurence of endpoints, Event adjudicated to be study endpoint, Report, Randomization, Serious Adverse Event, Intensity changes, Seriousness, Relevant concomitant/treatment medications, Relevant medical conditions / Risk factors, Relevant diagnostic results, Investigational product, Investigational product [hidden], Investigational product [hidden], General narrative comments, Non clinical
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: Serious adverse events - Repeating form (Scheduled visits)

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