Table 4.
Model-predicted ΔQTcP and ΔQTcF at avelumab Cmax in patients who received diphenhydramine in the 10 and 20 mg/kg dose cohorts of JAVELIN Solid Tumor
| Parameter | Dose level | Observed maximum geometric mean Cmax (μg/mL)a | Model-estimated ΔQTc at Cmax (ms) | 90% CI |
|---|---|---|---|---|
| ΔQTcP | 10 mg/kg | 307 | 3.492 | (2.141–4.842) |
| 20 mg/kg | 505 | 4.172 | (2.066–6.279) | |
| ΔQTcF | 10 mg/kg | 307 | 3.650 | (2.214–5.087) |
| 20 mg/kg | 505 | 4.650 | (2.423–6.877) |
Cmax maximum serum concentration, QTcF QTc derived from Fridericia’s formula, QTcP QTc derived from a project-specific formula
aGeometric mean values are the largest observed concentrations at the end of infusion in JAVELIN Solid Tumor across all visits, where n > 3