Efficacy and safety endpoints
fatigue/asthenia, death, hypertension, diarrhea
PALMAR-PLANTAR ERYTHRODYSESTHESIA, EVENTS, HYPERTENSION
Time-to-event analyses were performed to characterize the exposure–response relationship between cabozantinib exposure and PFS (defined as the time from randomization to radiographic progression per RECIST v1.1 by BICR, or death), cabozantinib dose modification, and each of the following AEs commonly associated with cabozantinib dose holds and reductions: palmar-plantar erythrodysesthesia (PPE; Grade ≥ 1), diarrhea (Grade ≥ 3), hypertension (Grade ≥ 3 [systolic BP > 160 mmHg or diastolic BP > 100 mmHg]), fatigue/asthenia (Grade ≥ 3), and alanine aminotransferase/aspartate aminotransferase (ALT/AST) elevation (Grade ≥ 3). An intended time-to-event analysis assessing the relationship of OS with cabozantinib exposure was not performed as there were too few events and limited follow-up at the time of the exposure–response analysis.