Table 2. Summary of Adverse Events.
| Adverse event | RT arm (n = 30) | TOS and ND arm (n = 31) | P valuea | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| G1 | G2 | G3 | G4 | G5 | G1 | G2 | G3 | G4 | G5 | ||
| Anemia | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .49 |
| Anorexia | 2 | 6 | 2 | 0 | 0 | 5 | 1 | 0 | 0 | 0 | .01 |
| Bone infection | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | >.99 |
| Constipation | 6 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | >.99 |
| Dehydration | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .49 |
| Dermatitis (radiation) | 12 | 5 | 1 | 0 | 0 | 11 | 5 | 0 | 0 | 0 | .69 |
| Dry mouth | 19 | 5 | 0 | 0 | 0 | 15 | 4 | 0 | 0 | 0 | .73 |
| Dysarthria | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | >.99 |
| Dysgeusia | 14 | 11 | 0 | 0 | 0 | 10 | 4 | 0 | 0 | 0 | .03 |
| Dyspepsia | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .49 |
| Dysphagia | 7 | 7 | 0 | 0 | 0 | 9 | 5 | 2 | 0 | 0 | .94 |
| Fatigue | 9 | 7 | 0 | 0 | 0 | 9 | 3 | 1 | 0 | 0 | .29 |
| Febrile neutropenia | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .49 |
| Fever | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .24 |
| Gastrointestinal disorder | 2 | 0 | 0 | 0 | 0 | 5 | 1 | 0 | 0 | 0 | >.99 |
| Hearing loss (based on audiogram) | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .49 |
| Hearing impairment (patient reported) | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .24 |
| Hypokalemia | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .49 |
| Hypomagnesemia | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .49 |
| Infection (other) | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .49 |
| Joint range of motion decreased | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | >.99 |
| Lung infection | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | .24 |
| Lymph leakage | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | >.99 |
| Mucositis (oral) | 9 | 5 | 1 | 0 | 0 | 3 | 3 | 1 | 0 | 0 | .51 |
| Musculoskeletal and connective tissue disorder | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | .49 |
| Nausea | 11 | 1 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 0 | >.99 |
| Neck pain | 1 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | >.99 |
| Neutrophil count decreased | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | .11 |
| Oral hemorrhage | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 1 | .05 |
| Oral/oropharyngeal pain | 9 | 2 | 0 | 0 | 0 | 5 | 4 | 0 | 0 | 0 | .67 |
| Osteonecrosis of jaw | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | >.99 |
| Pain (not otherwise specified) | 5 | 5 | 1 | 0 | 0 | 5 | 7 | 0 | 0 | 0 | .81 |
| Peripheral sensory neuropathy | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | .49 |
| Rash (maculopapular) | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | >.99 |
| Skin ulceration | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | >.99 |
| Thromboembolic event | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .49 |
| Thrush | 2 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | .49 |
| Tinnitus | 5 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .49 |
| Trismus | 0 | 1 | 0 | 0 | 0 | 5 | 3 | 2 | 0 | 0 | .20 |
| Vomiting | 4 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | >.99 |
| Weight loss | 8 | 2 | 0 | 0 | 0 | 11 | 3 | 0 | 0 | 0 | >.99 |
| White blood cell count decreased | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | .49 |
Abbreviations: G, grade; RT, radiotherapy; TOS and ND, transoral surgery and neck dissection.
a
P values calculated based on rates of grade 2 or greater adverse events using the χ2 or Fisher exact test as appropriate.