When we used the logistic regression model for univariate analysis, age, underlying disease (nonfatal versus ultimately or rapidly fatal), initial CRP level, initial absolute neutrophil count (ANC), peak CK level, and peak CRP level were predictors of death.

The most common grade 3 or greater toxicities observed in the treatment arms (ERBITUX plus FOLFIRI, ERBITUX plus FOLFOX, FOLFIRI alone, or FOLFOX alone) were diarrhea (22%, 14%, 15%, and 10%, respectively) and absolute neutrophil count (34%, 38%, 27%, and 36%, respectively).

Prescribing health care practitioners, dispensing pharmacists and FazaClo patients must be registered in the FazaClo Patient Registry, which will compare patient information against the National Non-Rechallenge Masterfile and maintain a continuing record of total white blood cell (WBC) counts and absolute neutrophil count (ANC) values and related information for all patients who receive the FazaClo brand of clozapine.