Pharmacodynamic Exploratory Analyses Sample Clauses

Pharmacodynamic Exploratory Analyses. Change in DENV viral load (as measured by viral titre) from baseline Area under the log10-transformed viral load curve (AUC) from first dose to the end of treatment (Day 5-6) and to study end (Day 28) (as measured by DENV RNA and viral titre) Time to viral load (as measured by DENV RNA and viral titre) or NS1 clearance, defined as time to first of 2 consecutive undetectable viral load or NS1, will be described using Xxxxxx-Xxxxx methods. The median time to viral clearance and the estimated proportions of patients with viral clearance will be summarized by treatment group. Patients who do not receive a record a negative test result by RT- PCR/viral titre or NS1 antigen assay by the last observation timepoint will be treated as censored at the final scheduled evaluation time point. Change of DENV viral load (as measured by DENV RNA and viral titre) from baseline, viral load AUC, time to viral load or NS1 clearance by DENV serotype Treatment-emergent amino acid substitutions in DENV NS5 gene Methods for analysis of time to resolution or duration of fever will be presented in the SAP Exploratory biomarkers may include plasma concentrations of cytokines (for example, TNF-α, IFN-γ, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IL-13, IL-1β, IP-10 and MCP-1) Exploratory analyses may be performed to evaluate exposure-response relationship. The relationship between the exposure of AT-752 (and its metabolites) and DENV viral load may be explored using graphical displays
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