Table 7.

Summary of TEAEs of clinical importance^a in the safety analysis set

N = 34, n (%)	Any Grade		≥ Grade 3		Treatment/response
	Adverse event	Drug related	Adverse event	Drug related	Dose discontinuation	Dose reduction	Patient withdrawn from studyb	Next cycle delayed
Blood toxicity
Neutropenia	14 (41)	13 (38)	13 (38)	12 (35)	3 (9)	6 (18)	1 (3)	10 (29)
Thrombocytopenia	13 (38)	13 (38)	8 (24)	8 (24)	3 (9)	4 (12)	2 (6)	5 (15)
Cardiac disorders
Cardiac failure	1 (3)	0	0	0	0	0	0	0
Gastrointestinal disorders
Nausea	10 (29)	9 (26)	0	0	0	0	0	0
Vomiting	5 (15)	5 (15)	1 (3)	1 (3)	0	1 (3)	1 (3)	0
Diarrhea	14 (41)	13 (38)	5 (15)	5 (15)	0	2 (6)	4 (12)	0
Dermatologic disorders	22 (65)	20 (59)	9 (26)	8 (24)	0	8 (24)	11 (32)	2 (6)
Rash	12 (35)	10 (29)	0	0	0	0	2 (6)	0
Maculopapular rash	5 (15)	5 (15)	4 (12)	4 (12)	0	4 (12)	4 (12)	0
Urticaria	4 (12)	3 (9)	0	0	0	0	0	0
Erythema multiforme	3 (9)	3 (9)	3 (9)	3 (9)	0	2 (6)	3 (9)	0
Generalized rash	1 (3)	1 (3)	1 (3)	1 (3)	0	1 (3)	1 (3)	1 (3)
Macular rash	1 (3)	1 (3)	1 (3)	1 (3)	0	1 (3)	1 (3)	1 (3)
Peripheral neuropathy
Peripheral sensory neuropathy	7 (21)	7 (21)	0	0	0	1 (3)	0	1 (3)
Peripheral neuropathy	1 (3)	1 (3)	0	0	0	0	0	0

TEAE treatment-emergent adverse event

^aTEAEs of clinical importance was not based on a safety signal in the review of the clinical data; rather, they were considered of clinical importance owing to other factors that included, but were not limited to: (1) identification by searches of the clinical database considering the context of the intended patient population; (2) common adverse reactions for lenalidomide; (3) AEs reported at higher rates both across ixazomib clinical trials and within the MM1 study; and (4) adverse reactions reported with the commercially available PIs bortezomib and carfilzomib

^bSome patients withdrew from the study due to multiple TEAEs