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Table 2 Summary of all adverse events reported by investigators in patients treated by nintedanib + pembrolizumab

From: Safety, recommended dose, efficacy and immune correlates for nintedanib in combination with pembrolizumab in patients with advanced cancers

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