Table 3.
Treatment-related adverse events, common terminology criteria for adverse events version 3.0 grade ≥ 3 treatment-related adverse events, and treatment-related serious adverse events
| Any treatment-related AEs* | Grade ≥ 3 treatment-related AEs | Any treatment-related SAEs | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PACX n = 158 | XP n = 147 | p value | PACX n = 158, (%) | XP n = 147, (%) | p value | PACX n = 158, (%) | XP n = 147, (%) | p value | ||
| Patients reporting AEs | 132 (83.5%) | 130 (88.4%) | 0.22 | 54 (34.2) | 59 (40.1) | 0.28 | Patients reporting SAEs | 6 (3.8) | 4 (2.7) | 0.60 |
| Blood and lymphatic system disorders | 104 (65.8%) | 108 (73.5%) | 0.15 | 43 (27.2) | 37 (25.2) | 0.69 | Drug hypersensitivity | 3 (1.9) | 0 (0.0) | 0.10 |
| Leukopenia | 77 (48.7%) | 99 (67.3%) | 0.001 | 20 (12.7) | 14 (9.5) | 0.38 | Agranulocytosis | 1 (0.6) | 0 (0.0) | 0.33 |
| Neutropenia | 78 (49.4%) | 79 (53.7%) | 0.45 | 33 (20.9) | 23 (15.6) | 0.24 | Neurotoxicity | 1 (0.6) | 0 (0.0) | 0.33 |
| Anemia | 40 (25.3%) | 45 (30.6%) | 0.30 | 3 (1.9) | 10 (6.8) | 0.03 | Multiple organ failure | 1 (0.6) | 0 (0.0) | 0.33 |
| Thrombocytopenia | 6 (3.8%) | 26 (17.7%) | < 0.0001 | 1 (0.6) | 7 (4.8) | 0.02 | Diarrhea | 1 (0.6) | 0 (0.0) | 0.33 |
| Gastrointestinal system disorders | 60 (38.0%) | 92 (62.6%) | < 0.0001 | 8 (5.1) | 18 (12.2) | 0.03 | Thrombocytopenia | 0 (0.0) | 1 (0.7) | 0.30 |
| Nausea | 26 (16.5%) | 61 (41.5%) | < 0.0001 | 3 (1.9) | 12 (8.2) | 0.01 | Hepatic function abnormal | 0 (0.0) | 1 (0.7) | 0.30 |
| Vomiting | 23 (14.6%) | 64 (43.5%) | < 0.0001 | 4 (2.5) | 14 (9.5) | 0.01 | Angioedema | 0 (0.0) | 1 (0.7) | 0.30 |
| Hypophagia | 15 (9.5%) | 32 (21.8%) | 0.003 | 0 (0.0) | 0 (0.0) | NA | Sudden death | 0 (0.0) | 1 (0.7) | 0.30 |
| Diarrhea | 7 (4.4%) | 9 (6.1%) | 0.51 | 0 (0.0) | 0 (0.0) | NA | Hemorrhage | 0 (0.0) | 1 (0.7) | 0.30 |
| Vascular disorders | 1 (0.6%) | 6 (4.1%) | 0.05 | 0 (0.0) | 0 (0.0) | NA | – | – | – | – |
| Alopecia | 14 (8.9%) | 1 (0.7%) | 0.001 | 0 (0.0) | 0 (0.0) | NA | – | – | – | – |
| Musculoskeletal and connective tissue disorders | 6 (3.8%) | 0 (0.0%) | 0.02 | 0 (0.0) | 0 (0.0) | NA | – | – | – | – |
| Abnormal laboratory test | 31 (19.6) | 32 (21.8) | 0.25 | 1 (0.6) | 5 (3.4) | 0.08 | – | – | – | – |
| Blood bilirubin elevation | – | – | – | 0 (0.0) | 3 (2.0) | 0.07 | – | – | – | – |
| Skin and subcutaneous tissue disorders | – | – | – | 3 (1.9) | 3 (2.0) | 0.93 | – | – | – | – |
| Palmar-plantar erythrodysesthesia syndrome | – | – | – | 2 (1.3) | 2 (1.4) | 0.94 | – | – | – | – |
| General disorders and administration site conditions | – | – | – | 2 (1.3) | 4 (2.7) | 0.36 | – | – | – | – |
| Fatigue | – | – | – | 1 (0.6) | 4 (2.7) | 0.15 | – | – | – | – |
All data are n (%)
AE adverse event, NA not applicable, PACX combination therapy of paclitaxel and capecitabine followed by capecitabine monotherapy as maintenance therapy, SAE serious adverse event, XP cisplatin and capecitabine combination therapy
*Only the AEs with prevalence ≥ 3% in either group are included in ‘Any treatment related AEs’