Review Article
A Systematic Literature Review of Adverse Events Associated with Systemic Treatments Used in Advanced Soft Tissue Sarcoma
Table 4
Patients experiencing selected other 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 |
| | Other AEs, (%) | | | Alopecia | | | Grade 1/2 | — | — | — | — | 1 (2) | 4 (7) | | Asthenia | | | All grades | — | — | — | — | 26 (50) | 43 (76) | | Grade 3 | — | — | — | — | 5 (10) | 4 (7) | | Grade 4 | — | — | — | — | — | — | | Cough | | | All grades | — | — | 23 (18) | 22 (17) | — | — | | Grade 3/4 | — | — | 0 (0) | 1 (<1) | — | — | | Dyspnea | | | All grades | — | — | 22 (17) | 36 (28) | — | — | | Grade 3/4 | — | — | 5 (4) | 8 (6) | — | — | Embolism (including pulmonary
and cerebrovascular) | | | Venous thromboembolic events | | | All grades | 3 (2) | 13 (5) | — | — | — | — | | Fatigue | | | All grades | 60 (49) | 155 (65) | 97 (75) | 89 (68) | — | — | | Grade 3 | 6 (5) | 30 (13) | — | — | — | — | | Grade 4 | 1 (1) | 1 (<1) | — | — | — | — | | Grade 3/4 | 7 (6) | 31 (13) | 10 (8) | 9 (7) | — | — | | Headache | | | All grades | — | — | 37 (28) | 34 (26) | — | — | | Grade 3/4 | — | — | 1 (<1) | 1 (<1) | — | — | | Hypertension | | | All grades | 8 (7) | 99 (41) | — | — | — | — | | Grade 3 | 4 (3) | 16 (7) | — | — | — | — | | Grade 4 | 0 (0) | 0 (0) | — | — | — | — |
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All grade 2.
AE: adverse event; ITT: intention to treat; IV: intravenous; q3wk: every 3 weeks.
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