Table 3.
Incidence of adverse events of special interest.
| AEs | Fulvestrant-palbociclib (n = 241) |
Letrozole-palbociclib (n = 242) |
||
|---|---|---|---|---|
| Any grade | Grade 3-5 | Any grade | Grade 3-4 | |
| Thromboembolic events | 14 (5.8) | 13 (5.0) | 11 (4.5) | 7 (2.9) |
| Pulmonary embolism a | 12 (5.0) | 12 (5.0) | 6 (2.5) | 6 (2.5) |
| Varicose vein | 0 | 0 | 2 (0.8) | 0 |
| Pelvic venous thrombosis | 0 | 0 | 1 (0.4) | 0 |
| Jugular vein thrombosis | 1 (0.4) | 0 | 0 | 0 |
| Ischemic stroke | 1 (0.4) | 1 (0.4) | 0 | 0 |
| Ischemic cardiomyopathy | 0 | 0 | 1 (0.4) | 0 |
| Cerebrovascular accident | 0 | 0 | 1 (0.4) | 1 (0.4) |
| ILD/pneumonitis b | 6 (2.5) | 2 (0.8) | 6 (2.5) | 3 (1.2) |
Data are presented as n (%), unless otherwise specified.
aOne patient in the fulvestrant–palbociclib group died due to unrelated pulmonary embolism.
bILD/pneumonitis included any reported preferred terms that were part of the Standardized MedDRA Query (narrow scope) interstitial lung disease.
Abbreviations: AEs, adverse events; ILD, interstitial lung disease.