Statement: Every patient in the Palbociclib+Letrozole Australia Cohort of the primary trial experienced Treatment-Emergent Adverse Events.
Primary_evidence: Outcome Measurement:    Number of Participants With Treatment-Emergent Adverse Events (All Causalities)   An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as treatment emergent adverse events (TEAEs). AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.   Time frame: Baseline up to 28 days after last dose of study treatment, an average of 14 months Results 1:    Arm/Group Title: Palbociclib+Letrozole India Cohort   Arm/Group Description: Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information   Overall Number of Participants Analyzed: 100   Measure Type: Count of Participants   Unit of Measure: Participants  Participants with adverse events: 92  92.0%   Participants with serious adverse events: 18  18.0%   Participants with grade 3 or 4 adverse events: 69  69.0%   Participants with grade 5 adverse events: 3   3.0%   Participants discontinued due to adverse events: 2   2.0% Results 2:    Arm/Group Title: Palbociclib+Letrozole Australia Cohort   Arm/Group Description: Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information   Overall Number of Participants Analyzed: 152   Measure Type: Count of Participants   Unit of Measure: Participants  Participants with adverse events: 152 100.0%   Participants with serious adverse events: 45  29.6%   Participants with grade 3 or 4 adverse events: 124  81.6%   Participants with grade 5 adverse events: 7   4.6%   Participants discontinued due to adverse events: 9   5.9%