Review Article
A Systematic Literature Review of Adverse Events Associated with Systemic Treatments Used in Advanced Soft Tissue Sarcoma
Table 5
Patients experiencing selected hematologic 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 |
| | Hematologic AEs, (%) | | | Anemia | | | All grades | 28 (23) | 65 (27) | 126 (97) | 117 (90) | 34 (65) | 47 (82) | | Grade 3 | 1 (1) | 11 (5) | 5 (4) | 9 (7) | 4 (8) | 2 (4) | | Grade 4 | 1 (1) | 4 (2) | 5 (4) | 3 (2) | 2 (4) | 0 (0) | | Febrile neutropenia | | | All grades | — | — | 1 (<1) | 1 (<1) | 3 (6) | 5 (9) | | Grade 3 | — | — | — | — | 2 (4) | 4 (7) | | Grade 4 | — | — | — | — | 1 (2) | 1 (2) | | Neutropenia | | | All grades | 8 (7) | 79 (33) | 96 (74) | 64 (49) | 28 (53) | 43 (76) | | Grade 3 | 0 (0) | 10 (4) | 34 (26) | 15 (12) | 7 (13) | 18 (32) | | Grade 4 | 0 (0) | 0 (0) | 27 (21) | 2 (2) | 10 (19) | 9 (16) | | Grade 3/4 | 0 (0) | 10 (4) | 61 (47) | 17 (13) | 17 (32) | 27 (48) | | Thrombocytopenia | | | All grades | 7 (6) | 86 (36) | 70 (54) | 36 (28) | 31 (60) | 23 (40) | | Grade 3 | 0 (0) | 7 (3) | 12 (9) | 6 (5) | 8 (15) | 1 (2) | | Grade 4 | 0 (0) | 2 (1) | 3 (2) | 1 (<1) | 6 (12) | 2 (4) |
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These data were reported on ClinicalTrials.gov: NCT00753688.
AE: adverse event; ITT: intention to treat; IV: intravenous; q3wk: every 3 weeks.
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