Table 4.

Adverse events.

OAW (N = 249)OETW (N = 260)
Adverse eventGrade 3Grade 4Grade 3Grade 4P
Acute toxicity
Hematologic
 Anemia8 (3.2%)2 (0.8%)4 (1.5%)1 (0.4%)0.16
 Thrombocytopenia11 (4.4%)1 (0.4%)2 (0.8%)1 (0.4%)0.015
 Neutropenia27 (10.8%)1 (0.4%)23 (8.8%)00.37
 Leucopenia60 (24.1%)8 (3.2%)41 (15.8%)1 (0.4%)0.002
Non-hematologic
 Stomatitis/mucositis89 (35.7%)085 (32.7%)1 (0.4%)0.53
 Vomiting28 (11.2%)033 (12.7%)00.62
 Nausea27 (10.8%)030 (11.5%)00.80
 Hiccups10 (4.0%)015 (5.8%)00.36
 Constipation4 (1.6%)04 (1.5%)0>0.99a
 Diarrhea4 (1.6%)09 (3.5%)00.18
 Dysphagia or odynophagia7 (2.8%)06 (2.3%)00.72
 Dermatitis15 (6.0%)022 (8.5%)00.29
 Xerostomia16 (6.4%)19 (7.3%)0.69
 Weight loss8 (3.2%)05 (1.9%)00.36
 Fever2 (0.8%)01 (0.4%)00.97a
 Ototoxicity2 (0.8%)03 (1.2%)0>0.99a
 Neurotoxicity001 (0.4%)0>0.99b
 Atrial fibrillation1 (0.4%)0000.49b
 Stroke0001 (0.4%)>0.99b
 Renal dysfunction1 (0.4%)0000.49b
 Transaminase elevation6 (2.4%)04 (1.5%)00.70a
 Hypokalemia11 (4.4%)012 (4.6%)1 (0.4%)0.76
 Hyponatremia10 (4.0%)2 (0.8%)20 (7.7%)2 (0.8%)0.10
 Hypocalcemia2 (0.8%)0000.24b
 Hypomagnesemia6 (2.4%)2 (0.8%)3 (1.2%)00.11
Any events grade ≥ 3150 (60.2%)15 (6%)138 (53.1%)7 (2.7%)0.015
Late toxicity
 Otitis4 (1.6%)02 (0.8%)00.64a
 Ototoxicity34 (13.7%)7 (2.8%)20 (7.7%)5 (1.9%)0.021
 Tinnitus3 (1.2%)02 (0.8%)00.96a
 Eye damage3 (1.2%)04 (1.5%)1 (0.4%)0.77a
 Vertigo3 (1.2%)02 (0.8%)00.96a
 Memory impairment3 (1.2%)04 (1.5%)0>0.99a
 Cranial neuropathy8 (3.2%)1 (0.4%)7 (2.7%)2 (0.8%)0.93
 Myelitis01 (0.4%)000.49b
 Peripheral neuropathy2 (0.8%)0000.24b
 Symptomatic temporal-lobe necrosis3 (1.2%)02 (0.8%)00.96a
 Bone necrosis01 (0.4%)000.49b
 Soft-tissue damage4 (1.6%)04 (1.5%)0>0.99a
 Trismus3 (1.2%)2 (0.8%)2 (0.8%)00.41a
 Xerostomia6 (2.4%)05 (2.0%)00.71
 Dysphagia4 (1.6%)02 (0.8%)00.64a
 Dysosmia3 (1.2%)6 (2.3%)0.54a
Any events grade ≥ 349 (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.