Table I.

Adverse events reported in ≥5% of patients treated with fedratinib 400 mg, with a difference between arms of >5% during randomised treatment; and selected laboratory abnormalities that worsened from baseline in ≥20% of fedratinib‐treated patients and with a difference between arms of >10%. ⁶

	Fedratinib 400 mg (n = 96)		Placebo (n = 95*)
	All grades	Grade ≥3†	All grades	Grade ≥3
	%
Adverse events‡
Diarrhoea	66	5	16	0
Nausea	62	0	15	0
Anaemia	40	30	14	7
Vomiting	39	3·1	5	0
Fatigue or asthenia	19	5	16	1·1
Muscle spasms	12	0	1·1	0
Blood creatinine increased	10	1	1·1	0
Pain in extremity	10	0	4·2	0
ALT increased	9	0	1·1	0
Headache	9	0	1·1	0
Weight increased	9	0	4·2	0
Dizziness	8	0	3·2	0
Bone pain	8	0	2·1	0
Urinary tract infection§	6	0	1·1	0
Dysuria	6	0	0	0
AST increased	5	0	1·1	0
Laboratory parameters
Haematology
Anaemia	74	34	32	10
Thrombocytopenia	47	12	26	10
Neutropenia	23	5	13	3·3
Biochemistry
Creatinine increased	59	3·1	19	1·1
ALT increased	43	1	14	0
AST increased	40	0	16	1·1
Lipase increased	35	10	7	2·2
Hyponatremia	26	5	11	4·3
Amylase increased‖	24	2·1	5	0

ALT, alanine aminotransferase; AST, aspartate aminotransferase.

^*1 patient randomised to placebo died before receiving study drug and is excluded from safety reporting.

^†Only one Grade 4 adverse event (anaemia) was reported in the fedratinib 400‐mg arm.

^‡Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

^§Includes cystitis.

^‖Without clinical pancreatitis.