Table 4.
Adverse events.
| OAW (N = 249) | OETW (N = 260) | ||||
|---|---|---|---|---|---|
| Adverse event | Grade 3 | Grade 4 | Grade 3 | Grade 4 | P |
| Acute toxicity | |||||
| Hematologic | |||||
| Anemia | 8 (3.2%) | 2 (0.8%) | 4 (1.5%) | 1 (0.4%) | 0.16 |
| Thrombocytopenia | 11 (4.4%) | 1 (0.4%) | 2 (0.8%) | 1 (0.4%) | 0.015 |
| Neutropenia | 27 (10.8%) | 1 (0.4%) | 23 (8.8%) | 0 | 0.37 |
| Leucopenia | 60 (24.1%) | 8 (3.2%) | 41 (15.8%) | 1 (0.4%) | 0.002 |
| Non-hematologic | |||||
| Stomatitis/mucositis | 89 (35.7%) | 0 | 85 (32.7%) | 1 (0.4%) | 0.53 |
| Vomiting | 28 (11.2%) | 0 | 33 (12.7%) | 0 | 0.62 |
| Nausea | 27 (10.8%) | 0 | 30 (11.5%) | 0 | 0.80 |
| Hiccups | 10 (4.0%) | 0 | 15 (5.8%) | 0 | 0.36 |
| Constipation | 4 (1.6%) | 0 | 4 (1.5%) | 0 | >0.99a |
| Diarrhea | 4 (1.6%) | 0 | 9 (3.5%) | 0 | 0.18 |
| Dysphagia or odynophagia | 7 (2.8%) | 0 | 6 (2.3%) | 0 | 0.72 |
| Dermatitis | 15 (6.0%) | 0 | 22 (8.5%) | 0 | 0.29 |
| Xerostomia | 16 (6.4%) | — | 19 (7.3%) | — | 0.69 |
| Weight loss | 8 (3.2%) | 0 | 5 (1.9%) | 0 | 0.36 |
| Fever | 2 (0.8%) | 0 | 1 (0.4%) | 0 | 0.97a |
| Ototoxicity | 2 (0.8%) | 0 | 3 (1.2%) | 0 | >0.99a |
| Neurotoxicity | 0 | 0 | 1 (0.4%) | 0 | >0.99b |
| Atrial fibrillation | 1 (0.4%) | 0 | 0 | 0 | 0.49b |
| Stroke | 0 | 0 | 0 | 1 (0.4%) | >0.99b |
| Renal dysfunction | 1 (0.4%) | 0 | 0 | 0 | 0.49b |
| Transaminase elevation | 6 (2.4%) | 0 | 4 (1.5%) | 0 | 0.70a |
| Hypokalemia | 11 (4.4%) | 0 | 12 (4.6%) | 1 (0.4%) | 0.76 |
| Hyponatremia | 10 (4.0%) | 2 (0.8%) | 20 (7.7%) | 2 (0.8%) | 0.10 |
| Hypocalcemia | 2 (0.8%) | 0 | 0 | 0 | 0.24b |
| Hypomagnesemia | 6 (2.4%) | 2 (0.8%) | 3 (1.2%) | 0 | 0.11 |
| Any events grade ≥ 3 | 150 (60.2%) | 15 (6%) | 138 (53.1%) | 7 (2.7%) | 0.015 |
| Late toxicity | |||||
| Otitis | 4 (1.6%) | 0 | 2 (0.8%) | 0 | 0.64a |
| Ototoxicity | 34 (13.7%) | 7 (2.8%) | 20 (7.7%) | 5 (1.9%) | 0.021 |
| Tinnitus | 3 (1.2%) | 0 | 2 (0.8%) | 0 | 0.96a |
| Eye damage | 3 (1.2%) | 0 | 4 (1.5%) | 1 (0.4%) | 0.77a |
| Vertigo | 3 (1.2%) | 0 | 2 (0.8%) | 0 | 0.96a |
| Memory impairment | 3 (1.2%) | 0 | 4 (1.5%) | 0 | >0.99a |
| Cranial neuropathy | 8 (3.2%) | 1 (0.4%) | 7 (2.7%) | 2 (0.8%) | 0.93 |
| Myelitis | 0 | 1 (0.4%) | 0 | 0 | 0.49b |
| Peripheral neuropathy | 2 (0.8%) | 0 | 0 | 0 | 0.24b |
| Symptomatic temporal-lobe necrosis | 3 (1.2%) | 0 | 2 (0.8%) | 0 | 0.96a |
| Bone necrosis | 0 | 1 (0.4%) | 0 | 0 | 0.49b |
| Soft-tissue damage | 4 (1.6%) | 0 | 4 (1.5%) | 0 | >0.99a |
| Trismus | 3 (1.2%) | 2 (0.8%) | 2 (0.8%) | 0 | 0.41a |
| Xerostomia | 6 (2.4%) | 0 | 5 (2.0%) | 0 | 0.71 |
| Dysphagia | 4 (1.6%) | 0 | 2 (0.8%) | 0 | 0.64a |
| Dysosmia | 3 (1.2%) | — | 6 (2.3%) | — | 0.54a |
| Any events grade ≥ 3 | 49 (19.7%) | 8 (3.2%) | 44 (16.9%) | 7 (2.7%) | 0.37 |
Note: Data are n (%). No grade 5 adverse events occurred during treatment. As prespecified by protocol, differences in adverse events were analyzed using χ² test. For adverse events that did not meet the requirement for χ² analysis (absolute count was <1), Fisher exact test was used.
Abbreviations: OAW, once-a-week group; OETW, once-every-3-weeks group.
aAdjusted χ² test.
bFisher exact test.