Table 4. Characteristics of adverse events (patient-level).
| Characteristics | Induction | Concurrent | |||
|---|---|---|---|---|---|
| AE | Value (N=637), n (%) | AE | Value (N=525), n (%) | ||
| Grade | |||||
| Mild AE (grade 1) | 40 (6.3) | Mild AE (grade 1) | 16 (3.0) | ||
| Moderate AE (grade 2) | 154 (24.2) | Moderate AE (grade 2) | 87 (16.6) | ||
| Severe AE (grade 3) | 223 (35.0) | Severe AE (grade 3) | 225 (42.9) | ||
| Life-threatening or disabling AE (grade 4 & 5) | 220 (34.5) | Life-threatening or disabling AE (grade 4 & 5) | 197 (37.5) | ||
| Top 10 of any grade AE | |||||
| Nausea | 347 (54.5) | Hemoglobin | 364 (69.3) | ||
| Hemoglobin | 320 (50.2) | Nausea | 272 (51.8) | ||
| Granulocytes/bands | 267 (41.9) | White blood count | 236 (45.0) | ||
| White blood count | 264 (41.4) | Platelets | 225 (42.9) | ||
| Pain | 228 (35.8) | Anorexia | 219 (41.7) | ||
| Lymphocytes | 224 (35.2) | Lymphocytes | 201 (38.3) | ||
| Vomiting | 201 (31.6) | Fatigue (asthenia, lethargy, malaise) | 192 (36.6) | ||
| Neutrophils/granulocytes (ANC/AGC) | 184 (28.9) | Esophagitis/dysphagia | 191 (36.4) | ||
| Anorexia | 178 (27.9) | Leukocytes | 170 (32.4) | ||
| Alopecia | 164 (25.7) | Vomiting | 166 (31.6 | ||
| Top 10 grade ≥3 AE | |||||
| Granulocytes/bands | 195 (44.0) | Lymphocytes | 179 (42.4) | ||
| Lymphocytes | 115 (26.0) | Lymphopenia | 93 (22.0) | ||
| White blood count | 113 (25.5) | White blood count | 89 (21.1) | ||
| Neutrophils/granulocytes (ANC/AGC) | 105 (23.7) | Leukocytes | 75 (17.8) | ||
| Nausea | 56 (12.6) | Granulocytes/bands | 72 (17.1) | ||
| Vomiting | 47 (10.6) | Dysphagia-esophageal related to radiation | 59 (14.0) | ||
| Leukocytes | 26 (5.9) | Neutrophils/granulocytes (ANC/AGC) | 58 (13.7) | ||
| Platelets | 26 (5.9) | Esophagitis/dysphagia | 57 (13.5) | ||
| Pain | 21 (4.7) | Platelets | 54 (12.8) | ||
| Anorexia | 20 (4.5) | Hemoglobin | 49 (11.6) | ||
| Total number of patients with grade ≥3 AE | n=443 | n=422 | |||
There were two patients who experienced grade 5 AEs (both in the induction phase, with infection), so we combined the results on grade 4 and grade 5 AEs. AE, adverse event; ANC, absolute neutrophil count; AGC, absolute granulocyte count.