Summary of Adverse Events Related to Study Treatment That Occurred in >2 Patients or Reported As CTCAE Grade 3 or Higher.

1If a patient had more than one event for a particular adverse event term, he/she is counted only once for that term and patient percentages are based on the total number of treated patients in the particular treatment group. There were no deaths attributed to study drug.2Herpes zoster was reported in two additional patients (both grade 2) but events were considered unrelated to GC1008. All 3 cases were treated with oral anti-viral agents and resolved within 1–2 weeks of diagnosis.3In CTCAE version 3, non life-threatening treatment related secondary malignancies are considered grade 3. Note: CTCAE version 4 added a new category “Neoplasms benign, malignant and unspecified” which corrected a lack of grade 1 and 2 designations. Under version 4, some of these lesions may have been considered grade 2. On review, the 2 cases diagnosed at the treating site as SCC were interpreted by the independent central review as representing KAs, and in one case involving a patient with prior SCC, an atypical squamous-epithelial-proliferation with KA-like features was read as most consistent with SCC.