Table 3.

Hematologic Toxicity During the First Cycle of Chemotherapy in 35 Patients Who Received Filgrastim Plus Placebo or PEG-rHuMGDF 0.3 μg/kg Through 5.0 μg/kg

Placebo + Filgrastim (n = 10)PEG-rHuMGDF* + Filgrastim (n = 25)P
Days to baseline platelet count 22 (18-28) 17 (9-28) .0143-151 
Days of ANC <1.0 × 109/L 2 (0-10) 3 (0-8) .663-152 
Days to baseline ANC count 12 (11-18) 12 (11-27) .963-151 
Patients with febrile neutropenia (n) 1.0ρ 
Maximum change in hematocrit −8% (−17% to −4%) −7% (−14% to 0%) 0.123-152 
Placebo + Filgrastim (n = 10)PEG-rHuMGDF* + Filgrastim (n = 25)P
Days to baseline platelet count 22 (18-28) 17 (9-28) .0143-151 
Days of ANC <1.0 × 109/L 2 (0-10) 3 (0-8) .663-152 
Days to baseline ANC count 12 (11-18) 12 (11-27) .963-151 
Patients with febrile neutropenia (n) 1.0ρ 
Maximum change in hematocrit −8% (−17% to −4%) −7% (−14% to 0%) 0.123-152 

Median (range) where given. Febrile neutropenia = temperature >38.2°C and ANC <1.0 × 109/L.

F3-150

Recovery for all patients administered doses of PEG-rHuMGDF of 0.3, 1.0, 3.0, or 5.0 μg/kg.

F3-151

Log-rank test.

F3-152

Rank sum test.

ρ Fisher's Exact test.

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