Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing email@example.com or calling +44 (0)1707 367554.
IMbrave150 study design1
- OS (assessed by blinded independent review; RECIST 1.1)
- PFS (assessed by blinded independent review; RECIST 1.1)
Secondary endpoints included:
- ORR and DoR (investigator and independently assessed by RECIST 1.1 and HCC-specific modified RECIST)
- Time to deterioration of QoL, physical functioning and role functioning (patient reported)
- Deterioration was defined as a decrease from baseline of ≥10 points on the EORTC QLQ–C30 maintained for 2 consecutive assessments or a decrease of ≥10 points in 1 assessment followed by death from any cause within 3 weeks
- Safety and side effect profiles were assessed on the basis of the nature, frequency and severity of AEs (according to NCI CTCAE version 4)
AE, adverse event; AFP, alpha-fetoprotein; CTCAE, common terminology criteria for adverse events; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGD, esophagogastroduodenoscopy; EORTC QLQ, European Organization for Research and Treatment of Cancer quality of life questionnaire; HCC, hepatocellular carcinoma; NCI, National Cancer Institute; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; QoL, quality of life; R, randomised; RECIST, response evaluation criteria in solid tumours.
- Finn RS et al. N Engl J Med 2020;382:1894–1905.
Date of preparation: December 2021.