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Trials - SLCTR/2019/037

Progress Report

Date Modified

2020-02-22


Period

6/months


Report Summary

EFFICACY RESULTS: • PLT count increased significantly for group 1 (25mg/d) and 2 (50mg/d) compared to control. • The proportion of the recovered patients were higher in group 1 (91%, OR:8.33, 95% CI: 2.11 to 32.80, p-value: 0.0024), and group 2 (91%, OR: 8.89, 95% CI: 2.26 to 34.89, p-value: 0.0017) in comparison to group 3 (55%) at day 7. SAFETY RESULTS: • In group 2 (50mg/D), 40% patients showed elevated SGOT and 27% patients showed elevated SGPT from baseline at day 4 compared to group 1 (25mg/D) and group 3. • Three patients of group 1 and seven patients of group 2 had PLT count above the upper normal limit (450×109/L) at day 7. • 25 mg/D appears to be safer than 50 mg/D. CONCLUSION: • Both doses of eltrombopag (25 mg/d and 50mg/d) were equally efficacious in correcting thrombocytopenia in dengue patients. • Administration of 25mg/D eltrombopag was safer than 50mg/d in dengue patients.


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