Table 2.
Summary of all adverse events reported by investigators in patients treated by nintedanib + pembrolizumab
| Nintedanib dose | Grade 1–2 | Grade 3–4 | ||
|---|---|---|---|---|
| 150 mg BID | 200 mg BID | 150 mg BID | 200 mg BID | |
| Alanine aminotransferase increased | 1 (16.7%) | 1 (16.7%) | 0 | 3 (50%) |
| Aspartate aminotransferase increased | 1 (16.7%) | 0 | 0 | 2 (33%) |
| Diarrhea | 3 (50%) | 1 (16.7%) | 0 | 0 |
| Hypothyroidism | 2 (33%) | 1 (16.7%) | 0 | 0 |
| Nausea | 2 (33%) | 1 (16.7%) | 0 | 0 |
| Vomiting | 2 (33%) | 1 (16.7%) | 0 | 0 |
| GGT increased | 0 | 1 (16.7%) | 0 | 1 (16.7%) |
| Fatigue | 1 (16.7%) | 1 (16.7%) | 0 | 0 |
| Abdominal pain | 1 (16.7%) | 1 (16.7%) | 0 | 0 |
| Decreased appetite | 2 (33%) | 0 | 0 | 0 |
| Cutaneous rash | 2 (33%) | 0 | 0 | 0 |
| Hypertension | 1 (16.7%) | 0 | 0 | 0 |
| Venous thromboembolism | 0 | 0 | 1 (16.7%) | 0 |
| Colitis | 1 (16.7%) | 0 | 0 | 0 |
| Creatinin increased | 0 | 1 (16.7%) | 0 | 0 |
| Dyspnea | 0 | 1 (16.7%) | 0 | 0 |
| Headache | 0 | 1 (16.7%) | 0 | 0 |
| Hearing impairment | 0 | 1 (16.7%) | 0 | 0 |
| Hyperthyroidism | 1 (16.7%) | 0 | 0 | 0 |
| Mucositis | 1 (16.7%) | 0 | 0 | 0 |
| Nervous system disorder | 0 | 1 (16.7%) | 0 | 0 |
| Peripheral motor neuropathy | 1 (16.7%) | 0 | 0 | 0 |
| Platelet count decreased | 1 (16.7%) | 0 | 0 | 0 |
| Renal and urinary disorder | 0 | 1 (16.7%) | 0 | 0 |
| Supraventricular tachycardia | 1 (16.7%) | 0 | 0 | 0 |
| Weight loss | 1 (16.7%) | 0 | 0 | 0 |