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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.