Baseline characteristics of the ibuprofen and placebo groups were balanced with respect to a variety of measures that correlate with mortality and morbidity. The mean interval that elapsed from the time the patient met the entry criteria to the administration of the study drug was 10.7 +/- 0.6 hours in the ibuprofen group and 11.3 +/- 0.6 hours in the placebo group. The predominant site of infection was the lung. In each group, infections associated with positive blood cultures were considered to have been treated with appropriate antibiotics in 96 percent of cases. Rates of organ dysfunction (organ failure) were similar in the two groups at the time of randomization, except that renal dysfunction was significantly more common in the placebo group.