Table 3.
Adverse Events
| Event | Experimental Arm |
Control Arm |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1 |
Grade 2 |
Grade 3 |
Grade 1 |
Grade 2 |
Grade 3 |
|||||||
| No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | |
| Induction chemotherapy | ||||||||||||
| Hematologic toxicity | 18 | 14.8 | 9 | 7.4 | 8 | 6.6 | — | — | — | — | — | — |
| Diarrhea | 11 | 9.0 | 6 | 4.9 | 1 | 0.8 | — | — | — | — | — | — |
| Alopecia | 83 | 68.0 | 3 | 2.5 | 0 | 0 | — | — | — | — | — | — |
| Nausea and/or vomiting | 66 | 54.1 | 2 | 1.6 | 0 | 0 | — | — | — | — | — | — |
| Altered liver function tests | 19 | 15.6 | 5 | 4.1 | 0 | 0 | — | — | — | — | — | — |
| Febrile neutropenia | — | — | — | — | 2 | 1.6 | — | — | — | — | — | — |
| Postoperative radiotherapy | ||||||||||||
| Oral mucositis | 38 | 34.2 | 44 | 39.6 | 7 | 6.3 | 41 | 36.3 | 43 | 38.1 | 7 | 6.2 |
| Trismus | 28 | 25.2 | 35 | 31.5 | 6 | 5.4 | 33 | 29.2 | 34 | 30.1 | 6 | 5.3 |
| Dermatitis | 31 | 27.9 | 41 | 36.9 | 5 | 4.5 | 29 | 25.7 | 38 | 33.6 | 4 | 3.5 |
| Dysphagia and odynophagia | 25 | 22.5 | 29 | 26.1 | 6 | 5.4 | 26 | 23.0 | 31 | 27.4 | 6 | 5.3 |