Defined as time from date of randomization to date of death due to any cause.

Defined as time from randomization until disease progression or death from any cause, whichever occurs first.

Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Number of participants with treatment emergent adverse events

Plasma concentration

Number of patients with dose limiting toxicity

Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)

Number of participants with treatment related adverse events

Blood plasma concentration

Number of participants with treatment related adverse events

Blood plasma concentration

Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)