Table 3.

Summary of treatment emergent adverse events in the phase I safety population

Measure, n (%)	All Patients (N = 14)
≥ 1 TEAE	14 (100)
≥ 1 TRAE	12 (86)
Grade 3/4 TEAE	10 (71)
Grade 3/4 TRAE	8 (57)
SAE*	6 (43)
≥ 1 TRSAE*	2 (14)
At least one DLT**	2 (14)
Discontinued due to ≥ 1 TEAE	3 (21)

Abbreviations: DLT, dose limiting toxicity; SAE, serious adverse events; TRAE, treatment-related adverse events; TRSAE, treatment-related serious adverse events

**Two patients had dose limiting toxicities; one patient dosed at selinexor 80 mg had grade 3 nausea and vomiting and one patient dosed at selinexor 60 mg experienced grade 4 neutropenia and thrombocytopenia

*Six patients were reported to have SAEs; two were considered related to study drug. One patient had treatment-related grade 3 anemia along with grade 2 pneumonitis and grade 3 dyspnea which were unrelated to treatment. Another patient experienced grade 4 thrombocytopenia with grade 3 hyponatremia and acute renal insufficiency. Of the 4 SAEs which were unrelated to study drug, one had grade 3 abdominal pain, one experienced grade 3 peritoneal infection requiring intravenous antibiotics and one patient had laryngeal bleeding which required bronchoscopy with bronchial artery embolization. The fourth patient had grade 3 lung infection/pneumonia which ultimately led to grade 5 adult respiratory distress syndrome which was unrelated to study drug