Spectrum and effect sizes (any grade and grade 3 or higher) of immune checkpoint inhibitor (ICI)-related adverse events, categorized by organ system/type, as reported in a systematic review and meta-analysis by Dang et al. [48]
| Adverse event category | Specific adverse events | Effect size (%)*, (any grade) | Effect size (%), (grade 3 or higher) |
|---|---|---|---|
| Fatigue | Ranging from mild to severe intensity | 14.95 | 0.74 |
| Dermatological reactions | Rash, pruritus (itching), vitiligo, erythema, dermatitis |
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| Gastrointestinal issues | Diarrhea, colitis, nausea, vomiting, abdominal pain |
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| Endocrinopathies | Hypothyroidism, hyperthyroidism, adrenal insufficiency, diabetes mellitus, hypophysitis |
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| Hepatotoxicity | Elevated liver enzymes, autoimmune hepatitis, jaundice |
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| Pulmonary toxicity | Pneumonitis, interstitial lung disease | Pneumonitis: 2.92 | Pneumonitis: 0.95 |
| Renal toxicity | Nephritis, acute kidney injury | Nephritis: 0.51 | Nephritis: 0.30 |
| Neurological issues | Peripheral neuropathy, encephalitis, Guillain-Barre syndrome, myasthenia gravis | Neuropathy: 1.02 | Neuropathy: 0.04 |
| Hematological toxicity | Thrombocytopenia, pancytopenia or immune aplastic anemia, neutropenia, anemia, cytokine release syndrome with hemophagocytic syndrome |
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* Data were pooled from 20 clinical trials involving 3,756 patients with recurrent or metastatic head and neck squamous cell carcinoma. Pooled incidences of specific adverse events reported in at least two studies are shown. Adverse events are classified as rare (< 0.1%, ≥ 0.01%) or very rare (< 0.01%). AST: aspartate aminotransferase; ALT: alanine aminotransferase