Exploratory analyses of patient-reported outcome measures suggested a delay in time to development of or worsening of shortness of breath in patients treated with Ceritinib as compared to chemotherapy. The patient-reported delay in onset or worsening of shortness of breath may be an overestimation, because patients were not blinded to treatment assignment.
The analysis by the BIRC assessment was similar to the analysis by the investigator assessment.
from FDA,2021.10