Skip to main content

Table 2 Data sets utilized for the establishment and validation of the granulopoiesis model

From: Pharmacokinetic and -dynamic modelling of G-CSF derivatives in humans

Type of data Disease G-CSF schedules Chemotherapy References
Phase I studies with Filgrastim none single application 3, 5, 10 μ g/kg none [31]
none single application 5, 10 μ g/kg none [60]
  none 10 applications 75, 150, 300, 600 μ g none [61]
  none 14 applications 30, 300 μ g none [62]
  none single application 4, 8 μ g/kg none [63]
Phase I studies with Pegfilgrastim none 30, 60, 100, 300 μ g/kg none [50]
Phase II studies with Pegfilgrastim LuCa 30, 100, 300 μ g/kg none [64]
  NHL 6000 μ g, day 2 CHOP [65]
Phase III studies with CX and w/wo Filgrastim NHL no G-CSF CHOP-21* [12]
NHL 480 μ g, day 4–13 CHOP-14* [12]
NHL 480 μ g, day 6–12 CHOP-14* [66]
Phase III studies with CX + Peg NHL 6000 μ g, day 2, 4 CHOP-14* [67]
  1. Studies with access to raw data are indicated with an asterisk. CX = chemotherapy, LuCa = lung cancer, NHL = high-grade non-Hodgkin’s lymphoma.