Shown here are the principal toxicities and the grades observed in patients receiving IL-12 that were not primarily attributed to another cause. All patients were assessable for toxicity. For patients receiving 100 ng/kg, n = 5; 300 ng/kg, n = 8; 500 ng/kg, n = 17; and 625 ng/kg, n = 4. Shown are all toxicities of grade 3 and above. In addition, anemia with hemolysis and other noteworthy toxicities of grade 2 are shown, as well as any grade of depression. In addition to these toxicities, (1) 1 patient on the 100-ng/kg dose had grade 3 anemia attributable to zidovudine; (2) 3 patients had elevated bilirubin levels (1 grade 3 and 2 grade 4) attributable to indinavir administration (and in one case also to sepsis); (3) 1 patient on the 300-ng/kg dose died of sepsis arising in a site of KS 1 week after stopping dosing, and 1 patient on the 500-ng/kg dose died of complications from concurrent multicentric Castleman disease and antithrombotic therapy administered for a possible pulmonary embolism. In addition, one patient on the 500-ng/kg dose developed a grade 4 elevated bilirubin and transaminases, which on investigation were found to be attributable to his taking at least twice the prescribed dose.

*In addition to the anemia with hemolysis toxicities noted, one patient on the 500-ng/kg dose and one patient on the 625-ng/kg dose was found to have increased hemolysis without anemia.

Constitutional symptoms observed were fevers, myalgias, and fatigue.