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. 2018 Dec 11;9(97):37042–37053. doi: 10.18632/oncotarget.26455

Table 1. Adverse events occurring in dogs in the phase I escalation study of EC0531.

Dose of EC0531 Number of dogs receiving that dose Number of doses given Adverse events defined by VCOG-CTCAE (G–Grade; DLT–Dose limiting toxicity)
0.18 1 6 1 dog with G1 anorexia
0.20 4 14 1 dog with G2 anorexia
0.22 4 10 1 dog with G1 lethargy
0.24 4 16 1 dog with G2 neutropenia
0.26 6 33 1 dog with G1 lethargy
1 dog with G1 vomiting and G1 neutropenia
1 dog with G2 neutropenia
1 dog with G3 neutropenia (DLT) and G2 diarrhea
0.28 10a,b 63 1 dog with G1 vomitinga
1 dog with G1lethargy and G3 weight loss (DLT)a
1 dog with G4 neutropenia (DLT)b
1 dog with G4 infusion reaction (DLT)b
0.30 2 15 1 dog with G3 neutropenia (DLT)
0.32 1 2 No adverse events observed
0.34 1 5 1 dog with G3 anorexia (DLT)

aFour dogs initially received a lower dose of EC0531, and then underwent intra-patient dose escalation to receive 0.28 mg/kg EC0531.

bSix new dogs were enrolled for which their initial dose of EC0531 was 0.28 mg/kg.