Safety Eventc | After Propensity Score Matchingb | ||||||||
---|---|---|---|---|---|---|---|---|---|
New users of palbociclib-fulvestrant (n = 561) | Historical new users of fulvestrant monotherapy (n = 561) | Hazard Ratio Estimates | |||||||
IR (per 100 person-years) | IR (per 100 person-years) | HR | 95% LCL | 95% UCL | |||||
IR | 95% LCL | 95% UCL | IR | 95% LCL | 95% UCL | ||||
Anemia | 47.7 | 40.0 | 56.5 | 26.2 | 21.1 | 32.2 | 1.8 | 1.4 | 2.3 |
Neutropenia | 36.7 | 30.0 | 44.5 | 4.6 | 2.7 | 7.4 | 7.8 | 4.7 | 13.0 |
Serious infection | 25.7 | 20.4 | 32.1 | 22.9 | 18.2 | 28.5 | 1.1 | 0.8 | 1.5 |
Thrombocytopenia | 10.5 | 7.2 | 14.7 | 4.6 | 2.7 | 7.4 | 2.3 | 1.3 | 4.1 |
QT prolongation | 6.4 | 3.9 | 9.9 | 3.5 | 1.9 | 6.0 | 1.8 | 0.9 | 3.5 |
Leukopenia | 5.4 | 3.1 | 8.6 | 0.8 | 0.2 | 2.4 | 6.4 | 1.9 | 21.9 |
Pulmonary embolism | 4.4 | 2.4 | 7.4 | 4.1 | 2.3 | 6.7 | 1.0 | 0.5 | 2.1 |
Acute liver injury (ALI)c | 4.1 | 2.2 | 6.9 | 0.8 | 0.2 | 2.4 | 4.8 | 1.4 | 16.9 |
Stomatitis and mucositis | 2.8 | 1.3 | 5.3 | 0.5 | 0.1 | 1.7 | 5.0 | 1.1 | 23.1 |