Table 4.

Patients With Adverse Events (Worst Grade) in the Safety Population

	Local Standard of Care (N = 27)		Trabectedin (N = 61)
CTC + MedDRA Term	Grade 3-5, N (%)	Grade 1-2, N (%)	Grade 3-5, N (%)	Grade 1-2, N (%)
Non-hematological adverse events
All grades	12 (44.4)	13 (48.1)	36 (59.0)	22 (36.1)
All grades, possibly related	5 (18.5)	15 (55.6)	21 (34.4)	25 (41.0)
Laboratory events
Hematological toxicity	4 (14.8)	18 (66.7)	34 (55.7)	22 (36.1)
Biochemical toxicity	2 (7.4)	20 (74.1)	38 (62.3)	23 (37.7)