Expansion cohort
toxicities, Toxicities
ADVERSE EVENTS, EVENT
The number of toxicities will be described by type and grade for each level (sequential and concomitant) according to the MedDRA classification. A listing of adverse events by patient and level will be provided.Each cohort will be analyzed separately. PFS and OS rates (at 6 and 12 months) and median PFS and their respective 95% CI will be determined using the Kaplan-Meier method to take censored data into account. Toxicities will be described by type and grade according to the MedDRA classification. In the event a patient experiences several toxicities of the same type, only the highest grade will be retained for analysis. A listing of adverse events by patient will be provided. Analyses will be performed using SAS 9.4 or a later version.