Table 3

End points in longitudinal analyses

EventsPFSFFSEFSOSATFS
No responses, or insufficient response to study therapy, after a predefined period of time*  Yes Yes   
Loss of responses to study treatment  Yes Yes   
Progression (AP/BC) Yes Yes Yes   
Adverse events leading to permanent discontinuation of study therapy (any grade)   Yes   
Treatment change     Yes 
Deaths Yes Yes Yes Yes Yes 
EventsPFSFFSEFSOSATFS
No responses, or insufficient response to study therapy, after a predefined period of time*  Yes Yes   
Loss of responses to study treatment  Yes Yes   
Progression (AP/BC) Yes Yes Yes   
Adverse events leading to permanent discontinuation of study therapy (any grade)   Yes   
Treatment change     Yes 
Deaths Yes Yes Yes Yes Yes 
*

Time point of assessment are defined in Table 1.

Discontinuation of treatment for patients in molecular response is not considered as a “treatment change” in this analysis.

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