A/E that led to discontinuation of IBRANCE in 6% of study patients .
Increases the plasma exposure of palbociclib.
# of months used to define disease-free interval.
Pharmacokinetics of IBRANCE has not been studied in patients with _____ renal impairment.
Abbreviation for cyclin-dependent kinase.
Hematologic toxicity.
The major efficacy outcome measure of the study.
Grade 3/4 _____ occurred in 5% of patients treated with IBRANCE and Letrozole.
Most frequently reported serious adverse reaction.
____ hepatic impairment had no effect on IBRANCE exposure.
AI used in combination with IBRANCE
Mean ______ is 46% after an oral dose of 125 mg.
A/E in 1% of study patients that led to discontinuation of IBRANCE.
Dose______ is recommended based on individual safety and tolerability.
29 hours
PFS was evaluated according to this.
Down
IBRANCE is an opaque hard _____ capsule.
Scale used to grade adverse events.
IBRANCE
IBRANCE is a _____ inhibitor
Occurred in 25% of all grades in the IBRANCE + Letrozole arm, no grade 3 or grade 4 reported.
Data not mature at the time of final analysis - with only 37% of events.
Food intake ____ the intersubject variability of Palbociclib exposure.
Decreased _______ counts were observed in clinical trials.
125 mg is the _________ starting dose.
Palbociclib is _______ by CYP 3A.
IBRANCE reduces cellular _________ of ER+ breast cancer cells.
IBRANCE + Letrozole combination increases the inhibition of the Rb _____________.
Palbociclib is a weak ____-dependent inhibitor of CYP following daily 125 mg dosing.
Term describing the potential fetal harm when administered to a pregnant woman.
What the Paloma 1 study is referred to as in the PI.
IBRANCE increased this drugs plasma exposure by 61%.
Use in _________ patients has not been studied.
No ______ neutropenia events were observed in Study 1.
Steady state of drug absorption was achieved after _____ days of repeated once daily dosing.
Advise women of childbearing age to use effective contraception for ____ weeks following IBRANCE therapy.
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