Black race population Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities for important identified and potential risks and missing information. Furthermore, additional activities are planned for some of the risks. These activities are summarised in Table 6. Table 6: Additional pharmacovigilance activities planned by the sponsor Additional activity Assigned safety Estimated concern proposed planned submission of final data TRA105325/ EXTEND Bone Marrow Extension study Final study Clinical Reticulin in adults with report Formation ITP long term September Category 3 safety including 2015 Ongoing collection of bone marrow reticulin TRA112940/ Bone Bone Marrow Safety in adults study Reticulin with ITP long report Marrow Study Formation term safety September Clinical including 2015 collection of Category 3 bone marrow Ongoing reticulin WWE116951: Thromboembolic TEE in patients Final study event (TEE) with HCV report Prospective associated December observational study of 2017 ENABLE clinical patients to understand later outcome patterns among patients with and without a Thromboembolic event. Pharmacoepidemiology Category 3 Ongoing Drug utilisation study Off label use Collect data of Final report use December ‘real-world’ Pharmacoepidemiology of Eltrombopag 2016 Category 3 post approval Ongoing GSK PASS Study: TEE and Hepatic Assess 6 months decompensation occurrence of interim
Black race population Pharmacovigilance plan The sponsor proposes routine pharmacovigilance activities for important identified and potential risks and missing information. Furthermore, additional activities are planned for some of the risks. These activities are summarised in Table 6. Table 6: Additional pharmacovigilance activities planned by the sponsor Additional activity Assigned safety concern proposed Estimated planned submission of final data TRA105325/ EXTEND Clinical Category 3 Ongoing Bone Marrow Reticulin Formation Extension study in adults with ITP long term safety including collection of bone marrow reticulin Final study report September 2015 TRA112940/ Bone Marrow Study Clinical Category 3 Ongoing Bone Marrow Reticulin Formation Safety in adults with ITP long term safety including collection of bone marrow reticulin study report September 2015 WWE116951: Prospective observational study of ENABLE clinical patients to understand later outcome patterns among patients with and without a Thromboembolic event. Pharmacoepidemiology Category 3 Ongoing Thromboembolic event (TEE) TEE in patients with HCV associated Final study report December 2017 Drug utilisation study Pharmacoepidemiology Category 3 Ongoing Off label use Collect data of ‘real-world’ use of Eltrombopag post approval Final report December 2016 GSK PASS Study: TEE and Hepatic decompensation Assess occurrence of 6 months interim