Table 3.
Safety profile for patients with or without stage IIIA-N2 NSCLC
| Patients with stage IIIA-N2 NSCLC |
Patients without stage IIIA-N2 NSCLCa |
|||
|---|---|---|---|---|
| Durvalumab (n = 195) | Placebo (n = 89) | Durvalumab (n = 280) | Placebo (n = 145) | |
| Any-grade all-causality AEs, n (%) | 189 (96.9) | 83 (93.3) | 271 (96.8) | 139 (95.9) |
| Grade 3/4 | 68 (34.9) | 22 (24.7) | 87 (31.1) | 44 (30.3) |
| Outcome of death | 9 (4.6) | 5 (5.6) | 12 (4.3) | 10 (6.9) |
| Leading to discontinuation | 32 (16.4) | 8 (9.0) | 41 (14.6) | 15 (10.3) |
| Serious AEs, n (%) | 59 (30.3) | 19 (21.3) | 79 (28.2) | 35 (24.1) |
| Any-grade pneumonitis/radiation pneumonitisb, n (%) | 72 (36.9) | 24 (27.0) | 89 (31.8) | 34 (23.4) |
| Grade 1 | 21 (10.8) | 11 (12.4) | 46 (16.4) | 14 (9.7) |
| Grade 2 | 39 (20.0) | 7 (7.9) | 33 (11.8) | 15 (10.3) |
| Grade 3 | 10 (5.1) | 3 (3.4) | 7 (2.5) | 3 (2.1) |
| Grade 4 | 0 | 0 | 0 | 0 |
| Grade 5 | 2 (1.0) | 3 (3.4) | 3 (1.1) | 2 (1.4) |
DCO = 22 March 2018 (DCO for the primary analysis of OS): median follow-up of 25.2 months (range: 0.2-43.1 months). AE, adverse event; DCO, data cut-off; NSCLC, non-small-cell lung cancer; OS, overall survival.
a
Patients with all other stages (including stages IIIA-N0/N1 and IIIB).
b
Pneumonitis/radiation pneumonitis is a composite term that includes events of acute interstitial pneumonitis, interstitial lung disease, pneumonitis, pulmonary fibrosis, and radiation pneumonitis (alveolitis and diffuse alveolar damage were also included, but no events were found).