A Systematic Literature Review of Adverse Events Associated with Systemic Treatments Used in Advanced Soft Tissue Sarcoma

Table 2

Patients experiencing selected liver-related AEs.

Study	van der Graaf et al., 2012 [11, 18]		Demetri et al., 2009 [15]		García-Del-Muro et al., 2011 [16]
Patient group	Treated		ITT (independent review)		Treated and analyzed
Treatment group	Placebo	Pazopanib	Trabectedin q3wk 24 h IV	Trabectedin weekly 3 h IV	Dacarbazine	Gemcitabine + dacarbazine
Liver-related AEs, (%)
AST elevation
All grades	27 (22)	122 (51)	122 (94)	85 (65)	—	—
Grade 3	2 (2)	13 (5)	41 (32)	4 (3)	—	—
Grade 4	0 (0)	6 (3)	0 (0)	0 (0)	—	—
ALT elevation
All grades	22 (18)	110 (46)	126 (97)	100 (77)	—	—
Grade 3	3 (2)	18 (8)	59 (45)	12 (9)	—	—
Grade 4	1 (1)	5 (2)	3 (2)	0 (0)	—	—
Bilirubin elevation
All grades	9 (7)	68 (28)	28 (22)	15 (12)	—	—
Grade 3	2 (2)	3 (1)	1 (<1)	1 (<1)	—	—
Grade 4	0 (0)	0 (0)	0 (0)	0 (0)	—	—

These data were reported on ClinicalTrials.gov: NCT00753688.
The number of patients with grade 3/4 bilirubin elevation differed slightly for the pazopanib group reporting in the article by van der Graaf et al. [11] and on ClinicalTrials.gov [18]. Because ClinicalTrials.gov had more information (all grades), this table shows the data from ClinicalTrials.gov.
AE: adverse event; ALT: alanine aminotransferase; AST: aspartate aminotransferase; ITT: intention to treat; IV: intravenous; q3wk: every 3 weeks.