Patient disposition, enrollment, and treatment. (A) Patient enrollment and analysis overview. Of the 125 ND unfit patients with AML screened using the blood-based biomarker test, 37 (30%) were RARA-positive and 88 (70%) were RARA-negative. The most frequent reasons for which screened ND unfit patients with AML were not enrolled included RARA-negative status before implementation of a protocol amendment allowing both RARA-positive and RARA-negative patients to enroll, and patients declined. Of the 51 patients with non-APL AML enrolled to receive tamibarotene and azacitidine, all were included in safety and efficacy analyses. The response-evaluable population comprised all patients enrolled who (1) completed 1 cycle of tamibarotene and had a follow-up assessment of disease status or (2) were withdrawn from the study before completion of cycle 1 because of documented disease progression. Figure includes patient status as of data cutoff, 14 February 2022. ∗No postbaseline response evaluation was performed for nonevaluable patients. (B) Patient disposition. ∗One patient died during treatment due to cardiac arrest that was not drug related; †Includes 2 patients who discontinued treatment before the first dose of tamibarotene. Of the 15 patients who discontinued because of AE, 3 patient discontinuations were assessed as related to study treatment; 1 was due to fatigue; 1 was due to fatigue, myalgia, arthralgia, and nausea, and 1 was due to pulmonary embolism. There were no hematologic AEs considered related to study treatment that led to treatment discontinuation.