Fig. 2: Patient disposition (all patients set).
a Berzosertib + gemcitabine cohorts. b Berzosertib + gemcitabine + cisplatin cohorts. aTwo patients in the berzosertib + gemcitabine group (one patient each due to receive berzosertib 210 mg/m2 + gemcitabine 500 mg/m2, berzosertib 210 mg/m2 + gemcitabine 750 mg/m2) never received study treatment due to renal failure before or on day 1. bTwo patients in the berzosertib 72 mg/m2 + gemcitabine 875 mg/m2 cohort completed treatment per the protocol version at the time, which limited treatment to six cycles. A later protocol amendment eliminated the restriction on duration of treatment, and thereafter no patient was considered to have completed treatment. cThis patient had an AE leading to berzosertib discontinuation, however, the primary reason for discontinuation was recorded as death by the investigator. Note: intra-patient dose escalation did not occur. For berzosertib in combination with gemcitabine, berzosertib 210 mg/m2 + gemcitabine 1000 mg/m2 (bold outline) was the recommended Phase 2 dose. AE adverse event.
