BONNER study: Most common adverse reactions1
- 6% of patients (13/208) discontinued ERBITUX due to any adverse reaction in the BONNER study
- ERBITUX-related adverse reactions leading to discontinuation included hypersensitivity reactions, grade 3 acneiform rash, and unspecified reason
†Adverse reactions occurring in ≥10% of patients in the ERBITUX combination arm and at a higher incidence (≥5%) compared to the radiation-alone arm.
‡Adverse reactions were graded using the National Cancer Institute Common Toxicity Criteria (NCI CTC), version 2.0.
§Includes cases also reported as infusion reaction.
ǁInfusion reaction defined as any event described at any time during the clinical study as “allergic reaction” or “anaphylactoid reaction,” or any event occurring on the first day of dosing described as “allergic reaction,” “anaphylactoid reaction,” “fever,” “chills,” “chills and fever,” or “dyspnea.”
¶Based on laboratory measurements, not on reported adverse reactions, the number of subjects with tested samples varied from 205-206 for ERBITUX with radiation arm; 209-210 for radiation alone.
#Acneiform rash defined as any event described as “acne,” “rash,” “maculopapular rash,” “pustular rash,” “dry skin,” or “exfoliative dermatitis.”