Table 2.
Most common drug-related adverse events in the safety analysis set
| Event | Arm A Nivolumab (N=15) | Arm B Capecitabine (N=15) | Arm C Nivolumab and Capecitabine (N=15) | |||
|---|---|---|---|---|---|---|
| All Grades | Grade 3 | All Grades | Grade 3 | All Grades | Grade 3 | |
| Number of patients (%) | ||||||
| Endocrine disorders: Hypothyroidism | 3 (20) | 0 | 0 | 0 | 2 (13.3) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 0 | 0 | 2 (13.3) | 0 | 5 (33.3) | 1 (6.7) |
| Diarrhea | 1 (6.7) | 0 | 7 (46.7) | 0 | 7 (46.7) | 2 (13.3) |
| Nausea | 0 | 0 | 4 (26.7) | 0 | 2 (13.3) | 0 |
| Oral mucositis | 0 | 0 | 3 (20) | 2 (13.3) | 3 (20) | 0 |
| General disorders: fatigue | 6 (40) | 0 | 5 (33.3) | 0 | 4 (26.7) | 2 (13.3) |
| Musculoskeletal and connective tissue disorders: arthralgia | 5 (33.3) | 0 | 1 (6.7) | 0 | 0 | 0 |
| Nervous system disorders: Peripheral sensory neuropathy | 0 | 0 | 3 (20) | 0 | 4 (26.7) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Palmar-plantar erythrodysesthesia syndrome | 0 | 0 | 7 (46.7) | 0 | 5 (33.4) | 0 |
| Skin and subcutaneous tissue disorders | 0 | 0 | 1 (6.7) | 0 | 4 (26.7) | 0 |