Table 4 Treatment-emergent adverse events of interest for nivolumab (100-day safety window).

From: A Phase 2 study of nivolumab in combination with modified FOLFIRINOX for metastatic pancreatic cancer

Adverse events preferred term

Any grade

Grade 3/4

Diarrhoea

7 (22.6)

0

Rash

4 (12.9)

0

Hypothyroidism

4 (12.9)

0

Interstitial lung diseasea

2 (6.5)

1 (3.2)

Gamma-glutamyltransferase increased

2 (6.5)

0

Alanine aminotransferase increased

1 (3.2)

0

Aspartate aminotransferase increased

1 (3.2)

0

Blood alkaline phosphatase increased

1 (3.2)

0

Adrenal disorder

1 (3.2)

0

  1. Data are presented as n (%) for adverse events observed between the first day of the regimen and 100 days after the last dose.
  2. There were no Grade 5 adverse events.
  3. aBoth events were serious drug-related adverse events.