Overview of studies included in PK–VK model development.

*T0821 (JapiCTI-153090) was a double-blind, dose-ranging, randomized trial (1:1:1:1) of single doses of baloxavir (10, 20, or 40 mg) versus placebo in OwH adult patients (age 20 to 64 years) with acute, uncomplicated influenza infection.[3] T0831 (NCT02954354; CAPSTONE-1) was a double-blind, randomized trial (2:2:1) of baloxavir versus oseltamivir or placebo in OwH adolescent and adult patients (age 12 to 64 years and ≥40 kg) with acute, uncomplicated influenza infection.[3] T0832 (NCT02949011; CAPSTONE-2) was a double-blind, randomized trial (1:1:1) of baloxavir versus oseltamivir or placebo in high-risk adolescent and adult patients (age ≥12 years and ≥40 kg) with acute, uncomplicated influenza infection.[5] T0821, T0831 and T0832 assessed the change from baseline in influenza virus titer over time.[3,5] In T0821, nasal or throat swabs were collected pre-dose at Visit 1 (Day 1), Visit 2 (Day 2), Visit 3 (Day 3; if circumstances permitted), Visit 4 (Days 5 to 7) and Visit 5 (Days 8 to 11).[25] In T0831 and T0832, nasopharyngeal/pharyngeal swabs were collected pre-dose on Day 1, and on study Days 2–6 and Day 9; Days 4 and 6 were optional visits.[3,5,25] †Data are shown for the influenza-positive ITTI population in T0821 and T0831, and for the modified ITTI population in T0832. ‡75 mg oseltamivir twice a day for 5 days. OwH, otherwise healthy; ITTI, intention-to-treat infected. (DOCX)