Safety and tolerability
death
DISEASE
AE monitoring was conducted daily during the trial. An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with use of ceftibuten. Each AE was assessed for its relationship to drug treatment (not related, unlikely, possible, and probable) with signs or symptoms graded on a 5-point severity scale (mild, moderate, severe, life-threatening, and death). Serious AE monitoring was conducted as part of the AE monitoring.