TABLE 4.
Adverse events associated with all cycles of CE therapy
| Event | Overall N = 63 | ECOG‐PS 2 N = 38 | ECOG‐PS ≥ 3 N = 25 | |||
|---|---|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Any adverse event, n (%) | 63 (100) | 51 (81.0) | 38 (100) | 30 (79.0) | 25 (100) | 21 (84.0) |
| White blood cell decreased | 54 (85.7) | 37 (58.7) | 31 (81.6) | 20 (52.6) | 23 (92.0) | 17 (68.0) |
| Neutrophil count decreased | 54 (85.7) | 43 (68.3) | 31 (81.6) | 24 (63.2) | 23 (92.0) | 19 (76.0) |
| Platelet count decreased | 52 (82.5) | 16 (25.4) | 32 (84.2) | 8 (21.1) | 20 (80.0) | 8 (32.0) |
| Anemia | 58 (92.1) | 14 (22.2) | 34 (89.5) | 10 (26.3) | 24 (96.0) | 4 (16.0) |
| Febrile neutropenia a | 13 (20.6) | 13 (20.6) | 6 (15.8) | 6 (15.8) | 7 (28.0) | 7 (28.0) |
| AST/ALT increased | 10 (15.9) | 2 (3.2) | 7 (18.4) | 0 | 3 (12.0) | 2 (8.0) |
| Creatinine increased | 4 (6.3) | 0 | 3 (7.9) | 0 | 1 (4.0) | 0 |
| Nausea | 8 (12.7) | 1 (1.6) | 3 (7.9) | 0 | 5 (20.0) | 1 (4.0) |
| Decreased appetite | 22 (34.9) | 3 (4.8) | 13 (34.2) | 1 (2.6) | 9 (36.0) | 2 (8.0) |
| Malaise | 6 (9.5) | 0 | 2 (5.3) | 0 | 4 (16.0) | 0 |
| Fatigue | 3 (4.8) | 0 | 1 (2.6) | 0 | 2 (8.0) | 0 |
| Cough | 6 (9.5) | 0 | 5 (13.2) | 0 | 1 (4.0) | 0 |
| Hiccups | 6 (9.5) | 0 | 4 (10.5) | 0 | 2 (8.0) | 0 |
| Mucositis oral | 5 (7.9) | 1 (1.6) | 2 (5.3) | 1 (2.6) | 3 (12.0) | 0 |
| Constipation | 21 (33.3) | 0 | 14 (36.8) | 0 | 7 (28.0) | 0 |
| Diarrhea | 5 (7.9) | 0 | 2 (5.3) | 0 | 3 (12.0) | 0 |
| Rash | 6 (9.5) | 0 | 5 (13.2) | 0 | 1 (4.0) | 0 |
| Vasculitis | 1 (1.6) | 0 | 0 | 0 | 1 (4.0) | 0 |
| Thromboembolic event | 1 (1.6) | 1 (1.6) | 1 (2.6) | 1 (2.6) | 0 | 0 |
| Aspiration b | 1 (1.6) | 1 (1.6) | 1 (2.6) | 1 (2.6) | 0 | 0 |
| Gastrointestinal hemorrhage c | 2 (3.2) | 1 (1.6) | 1 (2.6) | 1 (2.6) | 1 (4.0) | 0 |
| Atrial fibrillation | 1 (1.6) | 0 | 0 | 0 | 1 (4.0) | 0 |
| Pneumothorax | 1 (1.6) | 0 | 1 (2.6) | 0 | 0 | 0 |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CE, carboplatin plus etoposide; ECOG‐PS, Eastern Cooperative Oncology Groups Performance Status.
a
Including two treatment‐related death cases in the PS ≥3 group.
b
This event was one of the treatment‐related deaths in the PS 2 group.
c
Including one treatment‐related death case in the PS 2 group.