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A long term observational ocular safety study in adults who have received study medication (either active drug or placebo) in a phase II or III clinical study evaluating eltrombopag. The study will follow subjects for 2.5 years following their last ocular assessment on their prior treatment study (regardless of the therapeutic indication) and will describe long-term ocular safety with respect to changes in the lenses over time from all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Subjects who have participated in a prior eltrombopag study, receiving either placebo or eltrombopag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag | Drug | Subjects participated in a prior eltrombopag study, having received either eltrombopag or placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Description of the incidence of changes in lens over time | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory epidemiologic analyses of ocular data from patients previously enrolled in studies with eltrombopag. | 2.5 years |
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Inclusion Criteria:
Subjects are eligible for enrolment in the study if they have previously participated in an eltrombopag study, either phase II or III, and meet all of the following criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
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Subjects who participated in a prior eltrombopag study, regardless of indication, and have received either placebo or eltrombopag.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tucson | Arizona | 85724 | United States | ||
| GSK Investigational Site |
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| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | Richmond | Virginia | 23249 | United States |
| GSK Investigational Site | Kogarah | New South Wales | 2217 | Australia |
| GSK Investigational Site | Plovdiv | 4000 | Bulgaria |
| GSK Investigational Site | Sofia | 1756 | Bulgaria |
| GSK Investigational Site | Calgary | Alberta | T2N 4Z6 | Canada |
| GSK Investigational Site | Victoria | British Columbia | V8V 3P9 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3E 3P4 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2X 3J4 | Canada |
| GSK Investigational Site | Brno | 656 53 | Czechia |
| GSK Investigational Site | Prague | 140 21 | Czechia |
| GSK Investigational Site | Prague | 180 81 | Czechia |
| GSK Investigational Site | Caen | 14033 | France |
| GSK Investigational Site | Clichy | 92118 | France |
| GSK Investigational Site | Marseille | 13285 | France |
| GSK Investigational Site | Paris | 75571 | France |
| GSK Investigational Site | Pessac | 33604 | France |
| GSK Investigational Site | Rouen | 76031 | France |
| GSK Investigational Site | Vandœuvre-lès-Nancy | 54511 | France |
| GSK Investigational Site | Berlin | State of Berlin | 13353 | Germany |
| GSK Investigational Site | Shatin, New Territories | Hong Kong |
| GSK Investigational Site | Budapest | 1529 | Hungary |
| GSK Investigational Site | Bangalore | India |
| GSK Investigational Site | Chennai | 600010 | India |
| GSK Investigational Site | Kolkata | 700 054 | India |
| GSK Investigational Site | Mumbai | 400036 | India |
| GSK Investigational Site | San Giovanni Rotondo | Apulia | 71013 | Italy |
| GSK Investigational Site | Avellino | Campania | 83100 | Italy |
| GSK Investigational Site | Rome | Lazio | 00133 | Italy |
| GSK Investigational Site | Genoa | Liguria | 16132 | Italy |
| GSK Investigational Site | Brescia | Lombardy | 25123 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20132 | Italy |
| GSK Investigational Site | Milan | Lombardy | 20157 | Italy |
| GSK Investigational Site | Karachi | 75300 | Pakistan |
| GSK Investigational Site | Lima | Lima Province | Lima 41 | Peru |
| GSK Investigational Site | Lima | Lima 27 | Peru |
| GSK Investigational Site | Poznan | 61-866 | Poland |
| GSK Investigational Site | San Juan | Puerto Rico | 00909 | Puerto Rico |
| GSK Investigational Site | Moscow | 105 229 | Russia |
| GSK Investigational Site | Moscow | 117997 | Russia |
| GSK Investigational Site | Moscow | 125167 | Russia |
| GSK Investigational Site | Saint Petersburg | 191167 | Russia |
| GSK Investigational Site | Saint Petersburg | 197758 | Russia |
| GSK Investigational Site | Saint Petersburg | 198255 | Russia |
| GSK Investigational Site | Samara | 443011 | Russia |
| GSK Investigational Site | St'Petersburg | 191024 | Russia |
| GSK Investigational Site | Barcelona | 08907 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28034 | Spain |
| GSK Investigational Site | San Sebastián | 20014 | Spain |
| GSK Investigational Site | Santa Cruz de Tenerife | 38320 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
| GSK Investigational Site | Seville | 41014 | Spain |
| GSK Investigational Site | Stockholm | SE-141 86 | Sweden |
| GSK Investigational Site | Stockholm | SE-171 76 | Sweden |
| GSK Investigational Site | Montfleury | 1008 | Tunisia |
| GSK Investigational Site | Sfax | 3029 | Tunisia |
| GSK Investigational Site | Sousse | 4000 | Tunisia |
| GSK Investigational Site | Tunis | 1008 | Tunisia |
| GSK Investigational Site | Dnipropetrovsk | 49102 | Ukraine |
| GSK Investigational Site | Donetsk | 83114 | Ukraine |
| GSK Investigational Site | Kyiv | 01030 | Ukraine |
| GSK Investigational Site | Vinnytsia | 21021 | Ukraine |
| GSK Investigational Site | Plymouth | Devon | PL6 8DH | United Kingdom |
| GSK Investigational Site | Glasgow | Lanarkshire | G12 0YN | United Kingdom |
| GSK Investigational Site | London | NW1 2BU | United Kingdom |
| GSK Investigational Site | Morriston | SA6 6NL | United Kingdom |
| ID | Term |
|---|---|
| D011693 | Purpura |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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