Trial Outcomes & Findings for Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors (NCT NCT02255461)

NCT ID: NCT02255461

Last Updated: 2021-03-02

Results Overview

Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a dose-limiting toxicity (DLT) and the next higher dose level had been determined to be too toxic. Stratum I consisted of less-heavily pre-treated patients.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 35 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2021-03-02

Participant Flow

Patients between 4 and 21 years of age with histologically confirmed retinoblastoma protein (Rb1) positive, primary recurrent, progressive, or refractory central nervous system tumors were enrolled at Pediatric Brain Tumor Consortium member institutions. The first patient was enrolled on 12/8/2014 and the last patient was enrolled on 10/10/2018.

All 35 eligible patients enrolled were included. The 'Completed' row included patients who completed all protocol therapy or who experienced a protocol endpoint which took them off therapy. These included dose limiting toxicities and progression/relapse events. Adverse events not related to study agent were included in the 'Not Completed' row.

Participant milestones

Measure	Stratum I, Dose Level 1 (50 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 2 (75 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	3	12	6	4	10
Overall Study COMPLETED	3	10	5	4	8
Overall Study NOT COMPLETED	0	2	1	0	2

Reasons for withdrawal

Measure	Stratum I, Dose Level 1 (50 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 2 (75 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	0	1	0	0	1
Overall Study Withdrawal by Subject	0	0	1	0	1
Overall Study Not meet dose reduction BSA requirement	0	1	0	0	0

Baseline Characteristics

Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors

Baseline characteristics by cohort

Measure	Stratum I, Dose Level 1 (50 mg/m2) n=3 Participants Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 2 (75 mg/m2) n=12 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=6 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=10 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Total n=35 Participants Total of all reporting groups
Age, Continuous	16.6 years n=5 Participants	12.6 years n=7 Participants	9.3 years n=5 Participants	16.5 years n=4 Participants	10.5 years n=21 Participants	12.7 years n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	12 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants	23 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	8 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	20 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	7 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants	23 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Region of Enrollment United States	3 participants n=5 Participants	12 participants n=7 Participants	6 participants n=5 Participants	4 participants n=4 Participants	10 participants n=21 Participants	35 participants n=8 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Patients who were enrolled on stratum I and were evaluable for dose finding assessment were used to determine the MTD for stratum I.

Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a dose-limiting toxicity (DLT) and the next higher dose level had been determined to be too toxic. Stratum I consisted of less-heavily pre-treated patients.

Outcome measures

Measure	Stratum I n=19 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Maximum Tolerated Dose (MTD) of Palbociclib in Stratum I	75 mg/m2/day	—	—	—	—

PRIMARY outcome

Timeframe: 4 weeks

Population: Patients who were enrolled on stratum II and were evaluable for dose finding assessment were used to determine the MTD for stratum II.

Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a DLT and the next higher dose level had been determined to be too toxic. Stratum II consisted of heavily pre-treated patients.

Outcome measures

Measure	Stratum I n=11 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Maximum Tolerated Dose (MTD) of Palbociclib in Stratum II	75 mg/m2/day	—	—	—	—

PRIMARY outcome

Timeframe: 4 weeks

Population: Patients who received at least one dose of palbociclib were included in the analysis. One patient in stratum II dose level 2 who withdrew prior to beginning protocol therapy was excluded.

DLTs were defined as any of the following adverse events that were at least possibly related to palbociclib that occurred during the first 4 weeks of therapy regardless of expectedness. Hematologic DLTs included grade 3 neutropenia with fever and sepsis, grade 3 thrombocytopenia and/or requiring a platelet transfusion on 2 separate days within a 7-day period, or any grade 4 hematologic toxicity except lymphopenia. Non-hematologic DLTs included any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with some exceptions (e.g., nausea and vomiting of < 5 days; diarrhea and/or electrolyte disturbances which have not been maximally treated; AST/ALT elevation that returns to levels meeting eligibility criteria within 7 days of study drug interruption and does not recur upon restarting drug), or any grade 2 non-hematologic toxicity that persists for > 7 days and is considered medically significant or sufficiently intolerable by patients requires treatment interruption.

Outcome measures

Measure	Stratum I n=3 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=12 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=6 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=9 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Number of Patients Who Experienced Dose Limiting Toxicities (DLTs)	0 Participants	2 Participants	2 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to day 3

Population: Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.

On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Apparent volume of central compartment (Vc/F) was estimated using a non-compartmental method.

Outcome measures

Measure	Stratum I n=3 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=12 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=6 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=9 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Single Dose Apparent Volume of Central Compartment (Vc/F)	672 L/m^2 Interval 622.0 to 1189.0	741 L/m^2 Interval 562.0 to 1856.0	708 L/m^2 Interval 601.0 to 819.0	847 L/m^2 Interval 373.0 to 1153.0	850 L/m^2 Interval 398.0 to 3653.0

PRIMARY outcome

Timeframe: Up to day 3

Population: Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.

On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Elimination rate constant (Ke) was estimated using a non-compartmental method.

Outcome measures

Measure	Stratum I n=3 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=12 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=6 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=9 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Single Dose Elimination Rate Constant (Ke)	0.053 per hour Interval 0.045 to 0.055	0.053 per hour Interval 0.03 to 0.07	0.048 per hour Interval 0.023 to 0.083	0.051 per hour Interval 0.031 to 0.07	0.051 per hour Interval 0.014 to 0.097

PRIMARY outcome

Timeframe: Up to day 3

Population: Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.

On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Half-life (t1/2) was estimated using a non-compartmental method.

Outcome measures

Measure	Stratum I n=3 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=12 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=6 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=9 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Single Dose Half-life (t1/2)	13.0 hour Interval 12.5 to 15.5	13.0 hour Interval 9.9 to 22.8	14.6 hour Interval 8.4 to 29.8	13.8 hour Interval 10.0 to 22.0	13.5 hour Interval 7.1 to 48.7

PRIMARY outcome

Timeframe: Up to day 3

Population: Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.

On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Apparent oral clearance (CL/F) was estimated using a non-compartmental method.

Outcome measures

Measure	Stratum I n=3 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=12 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=6 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=9 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Single Dose Apparent Oral Clearance (CL/F)	35.8 L/h/m^2 Interval 34.4 to 53.1	38.4 L/h/m^2 Interval 29.3 to 72.0	33.7 L/h/m^2 Interval 17.3 to 63.3	37.2 L/h/m^2 Interval 16.9 to 64.3	24.4 L/h/m^2 Interval 11.7 to 355.0

PRIMARY outcome

Timeframe: Up to day 3

Population: Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.

On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Area under the plasma concentration time curve (AUC) was estimated using a non-compartmental method.

Outcome measures

Measure	Stratum I n=3 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=12 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=6 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=9 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Single Dose Area Under the Plasma Concentration Time Curve (AUC)	1156 h*ng/mL Interval 810.0 to 1164.0	1743 h*ng/mL Interval 892.0 to 2537.0	2407 h*ng/mL Interval 1485.0 to 3252.0	1289 h*ng/mL Interval 747.0 to 2834.0	2538 h*ng/mL Interval 189.0 to 2951.0

PRIMARY outcome

Timeframe: Up to day 22

Population: Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.

On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Apparent volume of central compartment (Vc/F) was estimated using a non-compartmental method.

Outcome measures

Measure	Stratum I n=2 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=10 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=3 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=8 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Steady State Apparent Volume of Central Compartment (Vc/F)	491 L/m^2 Interval 465.0 to 517.0	449 L/m^2 Interval 282.0 to 1560.0	442 L/m^2 Interval 383.0 to 501.0	705 L/m^2 Interval 250.0 to 1308.0	458 L/m^2 Interval 247.0 to 919.0

PRIMARY outcome

Timeframe: Up to day 22

Population: Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.

On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Elimination rate constant (Ke) was estimated using a non-compartmental method.

Outcome measures

Measure	Stratum I n=2 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=10 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=3 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=8 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Steady State Elimination Rate Constant (Ke)	0.052 per hour Interval 0.041 to 0.066	0.050 per hour Interval 0.017 to 0.11	0.062 per hour Interval 0.054 to 0.071	0.032 per hour Interval 0.024 to 0.049	0.039 per hour Interval 0.032 to 0.074

PRIMARY outcome

Timeframe: Up to day 22

Population: Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.

On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Half-life (t1/2) was estimated using a non-compartmental method.

Outcome measures

Measure	Stratum I n=2 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=10 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=3 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=8 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Steady State Half-life (t1/2)	13.7 hour Interval 10.5 to 16.9	13.7 hour Interval 6.5 to 41.6	11.3 hour Interval 9.8 to 12.8	23.1 hour Interval 14.2 to 29.4	17.9 hour Interval 9.4 to 21.4

PRIMARY outcome

Timeframe: Up to day 22

Population: Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.

On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Apparent oral clearance (CL/F) was estimated using a non-compartmental method.

Outcome measures

Measure	Stratum I n=2 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=10 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=3 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=8 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Steady State Apparent Oral Clearance (CL/F)	26.6 L/h/m^2 Interval 19.0 to 34.2	25.8 L/h/m^2 Interval 12.3 to 101.0	28.1 L/h/m^2 Interval 20.8 to 35.3	17.0 L/h/m^2 Interval 9.7 to 64.0	16.1 L/h/m^2 Interval 12.1 to 62.4

PRIMARY outcome

Timeframe: Up to day 22

Population: Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.

On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Area under the plasma concentration time curve (AUC) was estimated using a non-compartmental method.

Outcome measures

Measure	Stratum I n=2 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=10 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=3 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=8 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Steady State Area Under the Plasma Concentration Time Curve (AUC)	1211 h*ng/mL Interval 972.0 to 1450.0	2143 h*ng/mL Interval 521.0 to 4070.0	2193 h*ng/mL Interval 1520.0 to 3168.0	1410 h*ng/mL Interval 559.0 to 3301.0	2359 h*ng/mL Interval 952.0 to 4253.0

SECONDARY outcome

Timeframe: Up to 2 years

Population: Patients who received at least one dose of palbociclib were included in the analysis. One patient in stratum II dose level 2 who withdrew prior to beginning protocol therapy was excluded.

Objective responses included complete response (CR) and partial response (PR).

Outcome measures

Measure	Stratum I n=3 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) n=12 Participants Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=6 Participants Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 Participants Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=9 Participants Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Number of Subjects With Objective Responses	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 4 weeks

Population: It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between neutropenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded.

Neutrophil count decreased adverse events observed in course 1 that were at least possibly attributable to palbociclib were included in analysis. Based on the highest toxicity grade reported, all participants, irrespective of their dose level or stratum, were combined and classified into three categories: 0 = no toxicity reported, 1 = grade 1 or 2, and 2 = grade 3 or 4. Association between neutrophil count decreased and single dose palbociclib AUC for all participants was examined.

Outcome measures

Measure	Stratum I n=34 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Association Between Neutropenia and Single Dose Palbociclib AUC No neutropenia	1424.4 h*ng/mL Standard Deviation 966.3	—	—	—	—
Association Between Neutropenia and Single Dose Palbociclib AUC Grade 1 or 2 neutropenia	2166.3 h*ng/mL Standard Deviation 797.8	—	—	—	—
Association Between Neutropenia and Single Dose Palbociclib AUC Grade 3 or 4 neutropenia	1937.6 h*ng/mL Standard Deviation 621.8	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 4 weeks

Population: It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between lymphopenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded.

Lymphocyte count decreased adverse events observed in course 1 that were at least possibly attributable to palbociclib were included in analysis. Based on the highest toxicity grade reported, all participants, irrespective of their dose level or stratum, were combined and classified into three categories: 0 = no toxicity reported, 1 = grade 1 or 2, and 2 = grade 3 or 4. Association between Lymphocyte count decreased and single dose palbociclib AUC for all participants was examined.

Outcome measures

Measure	Stratum I n=34 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Association Between Lymphopenia and Single Dose Palbociclib AUC No lymphopenia	1727.5 h*ng/mL Standard Deviation 882.6	—	—	—	—
Association Between Lymphopenia and Single Dose Palbociclib AUC Grade 1 or 2 lymphopenia	1837.9 h*ng/mL Standard Deviation 592.7	—	—	—	—
Association Between Lymphopenia and Single Dose Palbociclib AUC Grade 3 or 4 lymphopenia	2159.0 h*ng/mL Standard Deviation 793.7	—	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 4 weeks

Population: It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between leukopenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded.

White blood cell count decreased adverse events observed in course 1 that were at least possibly attributable to palbociclib were included in analysis. Based on the highest toxicity grade reported, all participants, irrespective of their dose level or stratum, were combined and classified into three categories: 0 = no toxicity reported, 1 = grade 1 or 2, and 2 = grade 3 or 4. Association between white blood cell count decreased and single dose palbociclib AUC for all participants was examined.

Outcome measures

Measure	Stratum I n=34 Participants Of 21 patients enrolled on stratum I, 2 patients were not evaluable for dose finding assessment due to receiving less than required dose of study drug. The remaining 19 patients were used to determine the MTD for stratum I.	Stratum I, Dose Level 2 (75 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Association Between Leukopenia and Single Dose Palbociclib AUC No leukopenia	1420.3 h*ng/mL Standard Deviation 955.1	—	—	—	—
Association Between Leukopenia and Single Dose Palbociclib AUC Grade 1 or 2 leukopenia	1879.6 h*ng/mL Standard Deviation 682.6	—	—	—	—
Association Between Leukopenia and Single Dose Palbociclib AUC Grade 3 or 4 leukopenia	2171.6 h*ng/mL Standard Deviation 712.9	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At enrollment

CDK4 is a key component in signaling pathways inside normal cells and cancer cells. CDK4 copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At enrollment

CDK6 is a key component in signaling pathways inside normal cells and cancer cells. CDK6 copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At enrollment

Cyclin D1 is a key component in signaling pathways inside normal cells and cancer cells. Cyclin D1 copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At enrollment

Cyclin D2 is a key component in signaling pathways inside normal cells and cancer cells. Cyclin D2 copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At enrollment

Cyclin D3 is a key component in signaling pathways inside normal cells and cancer cells. Cyclin D3 copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At enrollment

Ink4a-ARF is a key component in signaling pathways inside normal cells and cancer cells. Ink4a-ARF loss copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At enrollment

Polymorphisms in ABCB1 encode for efflux-transporter proteins P-glycoprotein (P-gp), for which palbociclib has been shown as a substrate. Genomic DNA was to be isolated from peripheral blood samples from consenting patients to determine ABCB1 polymorphisms.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At enrollment

Polymorphisms in ABCG2 encode for BCRP, for which palbociclib has been shown as a substrate. Genomic DNA was to be isolated from peripheral blood samples from consenting patients to determine ABCG2 polymorphisms.

Outcome measures

Outcome data not reported

Adverse Events

Stratum I, Dose Level 1 (50 mg/m2)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Stratum I, Dose Level 2 (75 mg/m2)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 3 deaths

Stratum I, Dose Level 3 (95 mg/m2)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Stratum II, Dose Level 1 (50 mg/m2)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 1 deaths

Stratum II, Dose Level 2 (75mg/m2)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Measure	Stratum I, Dose Level 1 (50 mg/m2) n=3 participants at risk Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 2 (75 mg/m2) n=12 participants at risk Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=6 participants at risk Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 participants at risk Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=9 participants at risk Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Investigations Neutrophil count decreased	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 1/6 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.

Other adverse events

Measure	Stratum I, Dose Level 1 (50 mg/m2) n=3 participants at risk Less-heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 2 (75 mg/m2) n=12 participants at risk Less-heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum I, Dose Level 3 (95 mg/m2) n=6 participants at risk Less-heavily pre-treated patients received oral palbociclib daily at 95 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 1 (50 mg/m2) n=4 participants at risk Heavily pre-treated patients received oral palbociclib daily at 50 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.	Stratum II, Dose Level 2 (75mg/m2) n=9 participants at risk Heavily pre-treated patients received oral palbociclib daily at 75 mg/m2/day for 21 days followed by a week rest (one course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	41.7% 5/12 • Number of events 6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	33.3% 2/6 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	100.0% 4/4 • Number of events 8 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	66.7% 6/9 • Number of events 11 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 1/6 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Eye disorders Eye disorders - other, specify	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 2/12 • Number of events 2 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	33.3% 4/12 • Number of events 6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 1/6 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 1/4 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 2/12 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 1/4 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 1/4 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Flatulence	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Gastrointestinal disorders - other, specify	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 3/12 • Number of events 10 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 1/4 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Nausea	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 3/12 • Number of events 4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 1/4 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Stomach pain	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 2/12 • Number of events 4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 1/4 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	22.2% 2/9 • Number of events 4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	41.7% 5/12 • Number of events 5 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 1/6 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 1/4 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	33.3% 3/9 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
General disorders Pain	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Infections and infestations Mucosal infection	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 1/6 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 3/12 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	22.2% 2/9 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Investigations Alkaline phosphatase increased	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	22.2% 2/9 • Number of events 2 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Investigations Blood bilirubin increased	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Investigations Electrocardiogram qt corrected interval prolonged	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 1/6 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 1/4 • Number of events 2 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Investigations Investigations - other, specify	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 1/4 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Investigations Lymphocyte count decreased	66.7% 2/3 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	66.7% 8/12 • Number of events 44 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	50.0% 3/6 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	50.0% 2/4 • Number of events 10 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	44.4% 4/9 • Number of events 8 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Investigations Neutrophil count decreased	33.3% 1/3 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	83.3% 10/12 • Number of events 54 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	50.0% 3/6 • Number of events 6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	100.0% 4/4 • Number of events 13 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	77.8% 7/9 • Number of events 25 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	50.0% 6/12 • Number of events 23 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	50.0% 3/6 • Number of events 4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	50.0% 2/4 • Number of events 10 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	55.6% 5/9 • Number of events 13 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Investigations Weight loss	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Investigations White blood cell decreased	66.7% 2/3 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	83.3% 10/12 • Number of events 57 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	83.3% 5/6 • Number of events 10 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	100.0% 4/4 • Number of events 15 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	77.8% 7/9 • Number of events 22 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 2 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	75.0% 3/4 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Metabolism and nutrition disorders Hyperglycemia	66.7% 2/3 • Number of events 2 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Metabolism and nutrition disorders Hyperkalemia	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 2/12 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 1/6 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	22.2% 2/9 • Number of events 2 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 2/12 • Number of events 2 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 2 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 1/6 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - other, specify	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Nervous system disorders Ataxia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Nervous system disorders Dizziness	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 1/4 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 2 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 1/6 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Nervous system disorders Paresthesia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Renal and urinary disorders Proteinuria	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	11.1% 1/9 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/12 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 1/6 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	25.0% 3/12 • Number of events 3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	16.7% 2/12 • Number of events 2 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Vascular disorders Hypertension	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 2 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.
Vascular disorders Hypotension	0.00% 0/3 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	8.3% 1/12 • Number of events 1 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/6 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/4 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.	0.00% 0/9 • Up to 2 years after starting treatment Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included: a) grade 1 and 2 AEs if attribution was at least possibly related to palbociclib and b) all grade 3+ AEs on treatment and within 30 days off treatment. AEs that were at least possibly attributable to palbociclib were summarized in SAE and Other AE tables below. All mortality on this study were due to disease. One patient in stratum II dose level 2 withdrew prior to protocol therapy and was not at risk.

Additional Information

Jie Huang

St. Jude Children's Research Hospital

Phone: 9015955750

Email: jie.huang@stjude.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER