A phase I study of selinexor in combination with high-dose cytarabine and mitoxantrone for remission induction in patients with acute myeloid leukemia

Table 2 Adverse events observed in > 5% of patients

Adverse events	Total, n (%)	Grades 1 and 2	Grade 3	Grade 4	Grade 5
Febrile neutropenia	14 (70%)		14
Diarrhea	8 (40%)	8
Anorexia	6 (30%)	6
Electrolyte abnormalities	6 (30%)	6
Bacteremia	5 (25%)		5
Cardiac toxicity^b	5 (25%)	2	3
Nausea/vomiting	5 (25%)	4	1^a
Fatigue	5 (25%)	5
Pneumonia	4 (20%)		4
Alopecia	4 (20%)	4
Line-associated DVT	3 (15%)		3
Acute kidney injury	3 (15%)	3
Rash	3 (15%)	3
Mood disorders	3 (15%)	3
Clostridium difficile colitis	2 (10%)	2
Syncope/pre-syncope	2 (10%)	1	1
Upper respiratory infection	2 (10%)	2
Mucositis	2 (10%)	2
Transaminitis	2 (10%)	2
Psychosis	2 (10%)	2
Typhlitis	1 (5%)		1
Hypoxia	1 (5%)		1
Urinary tract infection	1 (5%)		1^a
Cerebellar toxicity	1 (5%)		1^a
Hemorrhagic stroke	1 (5%)				1^a
Cellulitis	1 (5%)		1^a
Endocarditis	1 (5%)		1^a
Total	93	55	37	0	1
	Adverse events occurring ≤ 5% not listed above: diverticulitis, edema, dysuria, musculoskeletal pain, vaginitis, plantar fasciitis, dry mouth, dysphagia, otitis externa, conjunctivitis, gingivitis, chest pain, hyperbilirubinemia, hypoalbuminemia, INR increased, peripheral neuropathy, and insomnia.

DVT deep vein thrombosis; INR international normalized ratio
^aSerious adverse event
^bCardiac toxicities included reduction in ejection fraction (2), atrial fibrillation (1), sinus bradycardia (1), and prolonged QT interval (2)

ISSN: 1756-8722