Table 3.
Adverse events (AEs) reported according to CTCAE v. 5.0.
| RCT N |
RCT+durvalumab N |
Total N (%) |
||
|---|---|---|---|---|
| Lung toxicity | ||||
| Pneumonitis or radiation pneumonitis* | 6 | 16 | 22 (25.9) | |
| Pneumonia | 2 | 1 | 3 (3.5) | |
| Other | 0 | 2 | 2 (2.4) | |
| Lung toxicity grade | ||||
| G1 | 1 | 7 | 8 (9.4) | |
| G2 | 3 | 9 | 12 (14.1) | |
| G3 | 2 | 3 | 5 (5.9) | |
| G4 | 1 | 0 | 1 (1.2) | |
| G5 | 1 | 0 | 1 (1.2) | |
| Endocrinological alterations | ||||
| G2 | 0 | 4 | 4 (7.7) | |
| G3 | 0 | 1 | 1 (1.9) | |
| Gastrointestinal | ||||
| G3 | 0 | 2 | 2 (3.8) | |
| Hematological | ||||
| G3 | 0 | 1 | 1 (1.9) | |
| Cutaneous | ||||
| G1 | 0 | 2 | 2 (3.8) | |
| G2 | 0 | 2 | 2 (3.8) | |
| G3 | 0 | 1 | 1 (1.9) | |
| Osteoarticular | ||||
| G2 | 0 | 3 | 3 (5.8) | |
RCT, randomized clinical trial; CTCAE, Common Terminology Criteria for Adverse Events.
*Pneumonitis includes acute interstitial pneumonitis, interstitial lung disease, pneumonitis, and pulmonary fibrosis.