Review Article
A Systematic Literature Review of Adverse Events Associated with Systemic Treatments Used in Advanced Soft Tissue Sarcoma
Table 3
Patients experiencing selected gastrointestinal and/or eating-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 |
| | Gastrointestinal and/or eating-related AEs, (%) | | | Anorexia/decreased appetite | | | All grades | 24 (20) | 95 (40) | 29 (22) | 21 (16) | — | — | | Grade 3 | 0 (0) | 14 (6) | — | — | — | — | | Grade 4 | 0 (0) | 0 (0) | — | — | — | — | | Grade 3/4 | 0 (0) | 14 (6) | 1 (<1) | 0 (0) | — | — | | Constipation | | | Grade 1/2 | — | — | 45 (35) | 42 (32) | — | — | | Grade 3/4 | — | — | 0 (0) | 2 (2) | — | — | | Decreased weight or weight loss | | | All grades | 25 (20) | 115 (48) | — | — | — | — | | Grade 3 | 0 (0) | 0 (0) | — | — | — | — | | Grade 4 | 0 (0) | 0 (0) | — | — | — | — | | Diarrhea | | | All grades | 20 (16) | 138 (58) | 31 (24) | 28 (22) | 3 (6) | 10 (18) | | Grade 3/4 | 1 (1) | 11 (5) | 1 (<1) | 0 (0) | 0 (0) | 0 (0) | | Nausea and/or vomiting | | | All grades | 34 (28) | 129 (54) | 97 (75) | 67 (52) | 8 (15) | 23 (40) | | Grade 3 | 2 (2) | 8 (3) | — | — | 1 (2) | 1 (2) | | Grade 4 | 0 (0) | 0 (0) | — | — | — | — | | Grade 3/4 | 2 (2) | 8 (3) | 7 (5) | 3 (2) | — | — | | Mouth or taste | | | Dysgeusia | | | All grades | 5 (4) | 64 (27) | — | — | — | — | | Grade 3 | 0 (0) | 0 (0) | — | — | — | — | | Grade 4 | 0 (0) | 0 (0) | — | — | — | — | | Mucositis | | | All grades | 4 (3) | 29 (12) | — | — | — | — | | Grade 3 | 0 (0) | 3 (1) | — | — | — | — | | Grade 4 | 0 (0) | 0 (0) | — | — | — | — |
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AE: adverse event; ITT: intention to treat; IV: intravenous; q3wk: every 3 weeks.
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