Table 3

Most common adverse events for subjects evaluable for toxicity.

IL-12 Dose (ng/kg) 0 10 30 100
Administration Route (number of subjects) s.c. (4) i.v. (3) s.c. (6) i.v. (3) s.c. (3) i.v. (3) s.c. (3) i.v. (3)
Event Toxicity Gradea Number of Patients Exhibiting Event
Fever less than or equal to 2 - - 2 - - 3 - 3
3 - - - - - - - -
Lethargy less than or equal to 2 - 3 - 3 - 3 1 1
3 - - - - - - - -
Nausea or vomiting less than or equal to 2 - 3 - 1 1 2 3 -
3 - - - - - 1 - -
Pain, including tumor pain less than or equal to 2 1 3 - - 1 3 2 1
3 - - - - - - - 1
Headache less than or equal to 2 - 2 - 1 - 3 - 1
3 - - - - - - - -

aUsing NCI CTC criteria. There were no grade IV toxicities.