Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study

Table 4 Common AEs reported in ≥10% of the safety population in either the ixazomib-Rd or placebo-Rd arm, plus other AEs of clinical importance

AE	Ixazomib-Rd (n = 57)			Placebo-Rd (n = 58)
AE	All grades	Grade 3	Grade 4	All grades	Grade 3	Grade 4
Common AEs, n (%)
Thrombocytopenia^a	39 (68)	10 (18)	4 (7)	36 (62)	8 (14)	3 (5)
Neutropenia^b	28 (49)	11 (19)	3 (5)	29 (50)	11 (19)	1 (2)
Anemia^c	20 (35)	7 (12)	0	31 (53)	15 (26)	1 (2)
Pneumonia^d	20 (35)	10 (18)	1 (2)	15 (26)	10 (17)	0
Upper respiratory tract infection	19 (33)	3 (5)	0	14 (24)	1 (2)	0
Leukopenia	17 (30)	5 (9)	0	10 (17)	1 (2)	0
Hepatotoxicity^e	12 (21)	3 (5)	0	5 (9)	0	0
Herpes zoster	12 (21)	4 (7)	0	2 (3)	0	0
Weight decreased	11 (19)	0	0	9 (16)	0	0
Diarrhea	10 (18)	1 (2)	0	4 (7)	0	0
Rash^f	10 (18)	0	0	12 (21)	0	0
Cough	9 (16)	0	0	3 (5)	0	0
Pyrexia	7 (12)	0	0	8 (14)	0	0
Hypokalemia	7 (12)	3 (5)	1 (2)	2 (3)	0	0
Bone pain	6 (11)	1 (2)	0	4 (7)	1 (2)	0
Insomnia	6 (11)	0	0	6 (10)	0	0
Lymphopenia	6 (11)	2 (4)	0	1 (2)	0	0
Fatigue	5 (9)	1 (2)	0	7 (12)	0	0
Hypoesthesia	4 (7)	0	0	7 (12)	0	0
Hyperglycemia	2 (4)	0	0	6 (10)	1 (2)	0
Other AEs of clinical interest, n (%)
Other gastrointestinal AEs
Nausea	5 (9)	0	0	2 (3)	0	0
Vomiting	5 (9)	0	0	2 (3)	0	0
Peripheral neuropathies^g	4 (7)	0	0	6 (10)	0	0
Cardiovascular AEs
Cardiac arrhythmias^h	3 (5)	1 (2)	0	2 (3)	0	0
Heart failureⁱ	1 (2)	0	0	3 (5)	1 (2)	1 (2)
Hypotension^j	1 (2)	0	0	0	0	0
Acute renal failure^k	2 (4)	0	0	5 (9)	2 (3)	0
New primary malignancy	0	0	0	1 (2)	0	1 (2)

^aPooled rate of preferred terms thrombocytopenia and platelet count decreased
^bPooled rate of preferred terms neutropenia and neutrophil count decreased
^cPooled rate of anemia and red blood cell analyses
^dPooled rate of pneumonia, lung infection, and bronchitis
^ePooled rate of eight preferred terms in the high-level terms of liver function analyses, tissue enzyme analyses, hepatic enzyme and function abnormalities, protein metabolism disorders, and peritoneal and retroperitoneal disorders; grade 3 events included 1 reversible elevation of alanine aminotransferase in a non-active hepatitis B-carrying patient, 1 hypoalbuminemia reported concurrently with progressive disease (and with no other liver function test abnormalities), and 1 transient increase in blood alkaline phosphatase in the context of development of complete response; no events were classed as serious adverse events or led to discontinuation
^fPooled rate of 19 rash-related preferred terms
^gModified high-level term of peripheral neuropathies not elsewhere classified
^hCardiac arrhythmias standardized MedDRA query (SMQ)
ⁱModified cardiac failure SMQ
^jModified vascular hypotensive disorder high-level term and vascular test high-level term
^kAcute renal failure SMQ

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