Table 1.

Overall response and durability results per investigator

Resultsn = 5895% CI
Objective response (%) 86 74.6-93.9* 
CR (%) 66 51.9-77.5* 
Partial response (%) 21  
Stable disease (%)  
Progressive disease (%)  
Not evaluable (%)  
Median duration of objective response (months) 25.6 11.8-NE 
Median duration of response in patients with CR (months) Not reached 20.0-NE 
Median PFS (months) 20.0 9.4-NE 
Median OS (months) Not reached 21.3-NE 
Resultsn = 5895% CI
Objective response (%) 86 74.6-93.9* 
CR (%) 66 51.9-77.5* 
Partial response (%) 21  
Stable disease (%)  
Progressive disease (%)  
Not evaluable (%)  
Median duration of objective response (months) 25.6 11.8-NE 
Median duration of response in patients with CR (months) Not reached 20.0-NE 
Median PFS (months) 20.0 9.4-NE 
Median OS (months) Not reached 21.3-NE 

NE, not estimable.

*

Two-sided 95% exact CI computed using the F distribution method.18 

Defined as patients determined to have systemic ALCL by local assessment, but not by central pathology review; scored as nonresponder per protocol.

Computed using the method of Brookmeyer and Crowley.19 

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