Assessments
Tumor, Pain, Cancer
DISEASE PROGRESSION, ADVERSE EVENT, TUMOR, ADVERSE EVENT, CANCER
Tumor response was assessed by imaging at screening, every 9 weeks for the first 54 weeks of treatment and every 12 weeks thereafter until disease progression or start of another anti-cancer treatment. Survival was assessed at least every 12 weeks during follow-up. Patients completed health-related quality of life assessments, including the EuroQOL EQ-5D-5L and the European Organization for Research and Treatment of Cancer QLQ-C30, QLQ-OG25 plus STO22 and Global Pain at screening, every 3 weeks during study treatment, at study treatment discontinuation and 30 and 90 days after study treatment discontinuation. Adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, were evaluated throughout the trial and for 90 days after study treatment discontinuation. Data were collected at study sites where study treatment was administered.