Table 3.
Treatment-related adverse events in the safety population
| Safety population (n=32) | |||
| Any grade | Grade 3 | Grade 4 | |
| Induction chemoimmunotherapy phase (n=32) | |||
| Any events | 32 (100.0) | 14 (43.8) | 2 (6.3) |
| Alopecia | 32 (100.0) | 0 | 0 |
| Decreased appetite | 32 (100.0) | 4 (12.5) | 0 |
| Nausea | 32 (100.0) | 0 | 0 |
| Hemoglobin decreased | 30 (93.8) | 0 | 0 |
| Pharyngodynia | 24 (75.0) | 0 | 0 |
| Fatigue | 22 (68.8) | 1 (3.1) | 0 |
| Dysphagia | 22 (68.8) | 0 | 0 |
| Leukopenia | 20 (62.5) | 3 (9.4) | 0 |
| Hoarseness | 19 (59.4) | 0 | 0 |
| Neutropenia | 17 (53.1) | 7 (21.9) | 2 (6.3) |
| Peripheral neuropathy | 16 (50.0) | 0 | 0 |
| γ-glutamyltransferase increased | 15 (46.9) | 1 (3.1) | 0 |
| Constipation | 15 (46.9) | 0 | 0 |
| Alanine aminotransferase increased | 14 (43.8) | 0 | 0 |
| Vomiting | 13 (40.6) | 1 (3.1) | 0 |
| Cough | 12 (37.5) | 0 | 0 |
| Pruritus | 11 (34.4) | 0 | 0 |
| Fever | 11 (34.4) | 1 (3.1) | 0 |
| Hypokalemia | 10 (31.3) | 0 | 0 |
| Rash | 10 (31.3) | 0 | 0 |
| Arthralgia | 10 (31.3) | 1 (3.1) | 0 |
| Blood bilirubin increased | 7 (21.9) | 0 | 0 |
| Creatinine increased | 7 (21.9) | 0 | 0 |
| cCRT with nimotuzumab phase (n=31) | |||
| Any events | 31 (100.0) | 23 (74.2) | 4 (12.9) |
| Decreased appetite | 31 (100.0) | 15 (48.4) | 0 |
| Nausea | 31 (100.0) | 3 (9.7) | 0 |
| Dry mouth | 31 (100.0) | 4 (12.9) | 0 |
| Subcutaneous tissue fibrosis | 31 (100.0) | 3 (9.7) | 0 |
| Radiation-induced oropharyngeal mucositis | 31 (100.0) | 14 (45.2) | 0 |
| Dermatitis radiation | 31 (100.0) | 11 (35.5) | 0 |
| Hemoglobin decreased | 31 (100.0) | 2 (6.5) | 0 |
| Fatigue | 29 (93.5) | 7 (22.6) | 0 |
| Hoarseness | 29 (93.5) | 3 (9.7) | 0 |
| Pharyngodynia | 28 (90.3) | 8 (25.8) | 0 |
| Dysphagia | 28 (90.3) | 5 (16.1) | 0 |
| Leukopenia | 27 (87.1) | 8 (25.8) | 3 (9.7) |
| Alopecia | 24 (77.4) | 0 | 0 |
| Peripheral neuropathy | 23 (74.2) | 3 (9.7) | 0 |
| Cough | 19 (61.3) | 0 | 0 |
| Constipation | 18 (58.1) | 0 | 0 |
| Neutropenia | 18 (58.1) | 6 (19.4) | 3 (9.7) |
| γ-glutamyltransferase increased | 17 (54.8) | 3 (9.7) | 0 |
| Pruritus | 17 (54.8) | 0 | 0 |
| Fever | 17 (54.8) | 2 (6.5) | 0 |
| Thrombocytopenia | 15 (48.4) | 3 (9.7) | 0 |
| Rash | 15 (48.4) | 1 (3.2) | 0 |
| Vomiting | 15 (48.4) | 2 (6.5) | 0 |
| Arthralgia | 15 (48.4) | 3 (9.7) | 0 |
| Alanine aminotransferase increased | 13 (41.9) | 1 (3.2) | 0 |
| Creatinine increased | 12 (38.7) | 0 | 0 |
| Hypokalemia | 12 (38.7) | 0 | 0 |
| Blood bilirubin increased | 10 (32.3) | 0 | 0 |
| Pneumonitis | 9 (29.0) | 0 | 1 (3.2) |
| Diarrhea | 8 (25.8) | 0 | 0 |
| Aspartate aminotransferase increased | 7 (22.6) | 1 (3.2) | 0 |
| Hyponatremia | 4 (12.9) | 2 (6.5) | 0 |
| Immunotherapy maintenance phase (n=30) | |||
| Any events | 30 (100.0) | 10 (33.3) | 2 (6.7) |
| Decreased appetite | 30 (100.0) | 6 (20.0) | 0 |
| Nausea | 30 (100.0) | 1 (3.3) | 0 |
| Fatigue | 28 (93.3) | 4 (13.3) | 0 |
| Hemoglobin decreased | 27 (90.0) | 1 (3.3) | 0 |
| Cough | 15 (50.0) | 0 | 0 |
| Constipation | 15 (50.0) | 0 | 0 |
| Pruritus | 13 (43.3) | 0 | 0 |
| Fever | 13 (43.3) | 1 (3.3) | 0 |
| Hypothyroidism | 12 (40.0) | 0 | 0 |
| Rash | 12 (40.0) | 1 (3.3) | 0 |
| Vomiting | 9 (30.0) | 0 | 0 |
| Pneumonitis | 8 (26.7) | 1 (3.3) | 1 (3.3) |
| Leukopenia | 7 (23.3) | 0 | 0 |
| Arthralgia | 7 (23.3) | 1 (3.3) | 0 |
| γ-glutamyltransferase increased | 5 (16.7) | 2 (6.7) | 0 |
| Neutropenia | 2 (6.7) | 1 (3.3) | 0 |
| Hyponatremia | 2 (6.7) | 1 (3.3) | 1 (3.3) |
Data are n (%). Safety population included all enrolled patients who received at least one dose of study treatment. The patient proportion of adverse events was calculated within the safety population for each treatment phase. Listed are adverse events of any grade with an incidence >20% and all grade 3–4 events in either group.
cCRT, concurrent chemoradiotherapy.