Table 3.

Grade ≥ 3 adverse events in the treated population

Adverse event	RVD induction N = 78 (%)	ASCT N = 59 (%)	Lenalidomide maintenance N = 54 (%)
Hematologic adverse events
Neutropenia	19 (24)	58 (98)	34 (63)
Febrile neutropenia	17 (22)	46 (78)	11 (20)
Thrombocytopenia	11 (14)	53 (90)	3 (6)
Anemia	6 (8)	15 (25)	0
Infections*	18 (23)		8 (15)
Gastrointestinal disorders	5(6)	3 (5)	0
Diarrhea	3 (4)	3 (5)	0
Hepatobiliary disorders	4^ (5)	0	1 (2)
Nervous system disorders	2 (3)	2 (3)	1 (2)e
Peripheral neuropathy	2 (3)	2 (3)	0
Skin disorders
Urticaria/rash	5 (6)	1 (2)	3 (6)
Dry skin	0	0	1 (2)
Thromboembolic event	3 (4)	2 (3)	1 (2)
Cardiac disorders	2 (3)	1 (2)	1 (2)
SPMs+	0	0	2 (4)
Other#	4 (5)	0	2 (4)

AE, adverse event; ASCT, autologous stem cell transplantation; RVD, lenalidomide, bortezomib, and dexamethasone; SPM, secondary primary malignancy

*Febrile neutropenias not included since reported separately

^One grade 5 adverse event, hepatorenal syndrome resulting in death

^eOne ADEM (acute disseminated encephalomyelitis)

⁺Basalioma during Len maintenance, squamocellular carcinoma of tonsilla, diagnosed 1 year after discontinuation of lenalidomide

^#During induction: bone pain 2 (3%), syncope 1 (1%), dyspnea 1 (1%), during maintenance interstitial pneumonia 1 (1%), pneumothorax 1 (1%)