Table 3 Selecta Incidence Rates and Propensity Score Adjustedb Hazard Ratios of the Safety Events Comparing New Users of Palbociclib and Fulvestrant and New Users of Fulvestrant Monotherapy

From: Real-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study

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
  1. Abbreviations: IR incidence rate, LCL lower confidence limit, UCL upper confidence limit, HR hazard ratio
  2. aResults for all safety events are provide in supplemental Table 5. Safety events selected for this table include notable safety events on the palbociclib product label or those of particular interest
  3. bThe following variables were included in the propensity score: age, region, Deyo-Charlson Index (DCI), number of outpatient visits, number of emergency room visits, secondary malignancy (i.e. metastases) to lymph nodes of head, face, and neck, secondary malignancy to other specified sites, secondary malignancy to respiratory and digestive sites (including to the liver), tamoxifen dispensing, everolimus dispensing, anastrazole dispensing, denosumab or pamidronate dispensing, exemestane dispensing, chemotherapy dispensing, corticosteroids dispensing, diagnostic imaging, breast cancer surgery, letrozole dispensing, HER2 positive therapy, radiation therapy, CT (computed tomography) imaging, mammography, MRI (magnetic resonance imaging), anticonvulsants, antidepressants, sedatives/hypnotics, secondary malignancy to breast, breast cancer diagnosis code, in situ breast cancer diagnosis, hyperglycemia, and cerebrovascular disease
  4. cAll algorithm definitions are provided in Supplemental Table 1. The “original” ALI algorithm for this active surveillance study is noted in this table as the “ALI or elevation of transaminases (ALI definition 2)”