Table 2.

Adverse events in patients treated with lenalidomide maintenance therapy (n=1097)

		Grade 1 or 2	Grade 3	Grade 4	Grade 5
Haematological
	Neutropenia	419 (38%)	308 (28%)	54 (5%)	0
	Anaemia	657 (60%)	40 (4%)	2 (<1%)	0
	Thrombocytopenia	489 (45%)	49 (4%)	23 (2%)	0
Infections
	Lower or upper respiratory infection	261 (24%)	89 (8%)	4 (<1%)	4 (<1%)
	Sepsis	1 (<1%)	12 (1%)	6 (1%)	2 (<1%)
	Other infections and infestations	104 (9%)	23 (2%)	0	0
Neurological
	Peripheral sensory neuropathy	319 (29%)	9 (1%)	0	0
Gastroenterological
	Constipation	312 (28%)	1 (<1%)	0	0
	Nausea	140 (13%)	2 (<1%)	0	0
Other
	Fatigue or lethargy	363 (33%)	15 (1%)	0	0
	Back pain	171 (16%)	5 (<1%)	0	0
	Rash	155 (14%)	8 (1%)	1 (<1%)	0
	Cough	137 (13%)	3 (<1%)	0	0
	Myalgia	128 (12%)	0	2 (<1%)	0
	Arthralgia	115 (10%)	5 (<1%)	0	0
	Cardiac disorder	0	0	0	1 (<1%)

Data are n (%). The table includes grade 1 or 2 adverse events occurring in at least 10% of patients and grade 3 or 4 events in at least 1% of patients (the rest of the grade 3 and 4 adverse events are in the appendix pp 26–28). All grade 5 events are shown. As per protocol, only serious adverse events were recorded in the observation group, and are presented in the appendix (p 29).