Table 4 Immune-related adverse events under immunotherapy in vaccinated and non-vaccinated patients

From: Cytokine release syndrome-like serum responses after COVID-19 vaccination are frequent and clinically inapparent under cancer immunotherapy

Characteristic, n (%, 95% CI)

Vaccinated (n = 64)

Unvaccinated (n = 26)

Any AE (irAE + non-irAE)

62 (96.9, 89.2–99.6)

25 (96.2, 80.4–1.0)

Grade ≥3 (irAE + non-irAE)

31 (48.4, 35.8–61.3)

18 (69.2, 48.2–85.7)

AI pneumonitis

2 (3.1, 0.4–10.8)

3 (11.5, 2.4–30.2)

AI colitis

5 (7.8, 2.6–17.3)

5 (19.2, 6.6–39.4)

AI hepatitis

6 (9.4, 3.5–19.3)

3 (11.5, 2.4–30.2)

AI hypophysitis

3 (4.7, 1.0–13.1)

1 (3.9, 0.1–19.6)

AI pancreatitis

0 (0.0, 0.0–5.6)

1 (3.9, 0.1–19.6)

AI nephritis

2 (3.1, 0.4–10.8)

1 (3.9, 0.1–19.6)

AI thrombocytopenia

0 (0.0, 0.0–5.6)

1 (3.9, 0.1–19.6)

AI hemolytic anemia

1 (1.6, 0.0–8.4)

0 (0.0, 0–13.2)

AI thyroiditis

3 (4.7, 1.0–13.1)

0 (0.0, 0–13.2)

AI myositis/arthritis

3 (4.7, 1.0–13.1)

1 (3.9, 0.1–19.6)

AI radiculitis

1 (1.6, 0.0–8.4)

0 (0.0, 0–13.2)

  1. Table indicating absolute numbers, frequencies and 95% CI of irAEs. The study has not been powered to evaluate the exact frequency of rare irAEs under ICI therapy and COVID-19 vaccination. The irAEs that are numerically more frequent in either the vaccinated or non-vaccinated group are marked in bold font.
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