Table 4.
Summary of safety in the Japan subgroup and the global study population
| Japan subgroup | Global study population | |||
|---|---|---|---|---|
| Durvalumab + EP (n = 18) | EP (n = 16) | Durvalumab + EP (n = 265) | EP (n = 266) | |
| Any event of any cause, n (%) | 18 (100) | 16 (100) | 260 (98) | 258 (97) |
| Any grade 3 or 4 event | 14 (78) | 15 (94) | 163 (62) | 166 (62) |
| Any event leading to death | 0 | 0 | 13 (5) | 15 (6) |
| Any serious event | 8 (44) | 8 (50) | 82 (31) | 96 (36) |
| Any event leading to discontinuationa | 0 | 0 | 25 (9) | 25 (9) |
| Any immune-mediated eventb | 4 (22) | 0 | 52 (20) | 7 (3) |
Listed are all adverse events that occurred during the treatment period and up to 90 days after the last dose of study treatment or up to the start of any subsequent therapy (whichever occurred first)
EP platinum-etoposide
aIncludes patients who permanently discontinued at least one study treatment
bAn immune-mediated adverse event was defined as an event that was associated with drug exposure and was consistent with an immune-mediated mechanism of action, where there was no clear alternate etiology and the event required treatment with systemic corticosteroids or other immunosuppressants and/or, for specific endocrine events, endocrine therapy