Table 4 Most common any-grade (reported in ≥10% of patients in either arm) and Grade ≥3 TEAEs (reported in ≥5% of patients in either arm), plus rates of additional TEAEs of clinical importance, reported with ixa-dex and pom-dex in the safety population.

From: Oral ixazomib-dexamethasone vs oral pomalidomide-dexamethasone for lenalidomide-refractory, proteasome inhibitor-exposed multiple myeloma: a randomized Phase 2 trial

MedDRA preferred term/higher-level term/SMQ/pooled term, n (%)	Ixa-dex n = 72		Pom-dex n = 47
	Any grade	Grade ≥ 3	Any grade	Grade ≥ 3
Diarrhea	29 (40)	4 (6)	13 (28)	0
Thrombocytopenia^a	27 (38)	23 (32)	12 (26)	9 (19)
Peripheral neuropathy^a	21 (29)	2 (3)	3 (6)	0
Fatigue	17 (24)	1 (1)	11 (23)	2 (4)
Insomnia	16 (22)	1 (1)	5 (11)	0
Anemia	13 (18)	11 (15)	18 (38)	14 (30)
Nausea	12 (17)	1 (1)	7 (15)	0
Pneumonia	12 (17)	10 (14)	11 (23)	11 (23)
Vomiting	10 (14)	1 (1)	4 (9)	0
Peripheral edema	10 (14)	2 (3)	2 (4)	0
Arrhythmias^a	9 (13)	4 (6)	5 (11)	4 (9)
Constipation	9 (13)	0	8 (17)	0
Rash^a	9 (13)	1 (1)	7 (15)	0
Back pain	8 (11)	0	2 (4)	0
Bronchitis	8 (11)	2 (3)	6 (13)	0
Upper respiratory tract infection	7 (10)	0	6 (13)	0
Urinary tract infection	5 (7)	2 (3)	6 (13)	0
Asthenia	4 (6)	0	8 (17)	3 (6)
Cough	4 (6)	0	6 (13)	0
Dyspnea	4 (6)	0	5 (11)	0
Pyrexia	3 (4)	0	7 (15)	2 (4)
Neutropenia^a	2 (3)	2 (3)	21 (45)	21 (45)
Pruritus	0	0	5 (11)	0
Other TEAEs of clinical importance
Heart failure^a	3 (4)	3 (4)	2 (4)	2 (4)
Renal impairment^a	2 (3)	1 (1)	3 (6)	2 (4)
Liver impairment^a	2 (3)	1 (1)	1 (2)	0
Hypotension^a	1 (1)	0	3 (6)	0
Encephalopathy^a	1 (1)	0	0	0
New primary malignancies	1 (1)		3 (6)

Dex dexamethasone, HLT high level term, ixa ixazomib, MedDRA Medical Dictionary for Regulatory Activities, pom pomalidomide, SMQ standardized MedDRA query, TEAE treatment-emergent adverse event.
^aHigher-level term, SMQ, or pooled term incorporating multiple preferred terms. Peripheral neuropathy preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, peripheral sensorimotor neuropathy. Thrombocytopenia preferred terms: thrombocytopenia, platelet count decreased. Rash preferred terms: acute febrile neutrophilic dermatosis, dermatitis acneiform, dermatitis allergic, drug eruption, erythema multiforme, exfoliative rash, interstitial granulomatous dermatitis, pruritus, pruritus generalized, purpura, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculo-papular, rash maculovesicular, rash morbilliform, rash papular, rash pruritic, rash pustular, rash vesicular, red man syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, urticaria papular, vasculitic rash. Arrhythmias: cardiac arrhythmias SMQ (broad). Heart failure: modified cardiac failure (broad) SMQ (excluding preferred terms of edema, edema peripheral, and peripheral swelling). Neutropenia preferred terms: neutropenia, neutrophil count decreased. Renal impairment: acute renal failure SMQ (broad). Liver impairment: cholestasis and jaundice of hepatic origin SMQ (broad), hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions SMQ (broad), liver-related investigations signs and symptoms SMQ (broad). Hypotension: modified vascular hypotensive disorders HLT (excluding preferred terms of systemic inflammatory response syndrome and vasoplegia syndrome), vascular test HLT (including only preferred terms related to blood pressure decreased). Encephalopathy: non-infectious encephalopathy/delirium SMQ (narrow). Myocardial infarction: myocardial infarction SMQ (broad).

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Table 4 Most common any-grade (reported in ≥10% of patients in either arm) and Grade ≥3 TEAEs (reported in ≥5% of patients in either arm), plus rates of additional TEAEs of clinical importance, reported with ixa-dex and pom-dex in the safety population.

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