A randomized, double-blind, placebo-controlled phase 2 study evaluating the efficacy and safety of romiplostim treatment of patients with low or intermediate-1 risk myelodysplastic syndrome receiving lenalidomide

Table 3 Number (%) of patients who reported adverse events during the treatment period

n (%)	Placebo	Romiplostim
		500 μg	750 μg
	(N = 9)^*	(N = 14)^†	(N = 14)^‡
Any adverse event (AE) ^§	8 (89)	14 (100)	14 (100)
Grade 3	5 (56)	5 (36)	8 (57)
Grade 4	1 (11)	4 (29)	2 (14)
Most frequently reported AEs
Fatigue	1 (11)	4 (29)	8 (57)
Thrombocytopenia	3 (33)	7 (50)	3 (21)
Diarrhea	5 (56)	5 (36)	5 (36)
Rash	2 (22)	5 (36)	5 (36)
Nausea	0 (0)	4 (29)	5 (36)
IP-related adverse events	2 (22)	7 (50)	5 (36)
Serious adverse events	6 (67)	5 (36)	4 (29)
Most frequently reported SAEs
Thrombocytopenia	0 (0)	3 (21)	1 (7)
Anemia	0 (0)	1 (7)	2 (14)
Back pain	0 (0)	2 (14)	0 (0)
Febrile neutropenia	0 (0)	1 (7)	1 (7)
Hyperkalemia	0 (0)	1 (7)	1 (7)
IP-related SAE	1 (11)	1 (7)	0 (0)
Cerebrovascular accident	1 (11)	0 (0)	0 (0)
Worsening thrombocytopenia^¶	0 (0)	1 (7)	0 (0)
Deaths	0 (0)	0 (0)	0 (0)
AE leading to study withdrawal or IP discontinuation	3 (33)	2 (14)	1 (7)

Legend: AE adverse event, SAE serious adverse event, IP investigational product.
^* The placebo group of the safety analysis set included the nine patients who received only placebo during the treatment period.
^† The romiplostim 500 μg group of the safety analysis set included the 13 patients treated with romiplostim 500 μg during the treatment period plus one patient originally randomized to the placebo group who inadvertently received one dose of romiplostim 500 μg during the treatment period.
^‡ The romiplostim 750 μg group of the safety analysis set included the 13 patients treated with romiplostim 750 μg during the treatment period plus one patient originally randomized to the placebo group who inadvertently received one dose of romiplostim 750 μg during the treatment period.
^§ No Grade 5 adverse events were reported.
^¶ This event was reported 4 weeks after the patient’ s last dose of romplostim during the treatment period.

ISSN: 1756-8722