Trial Outcomes & Findings for Palbociclib in Real World Practice (NCT NCT03280303)

NCT ID: NCT03280303

Last Updated: 2024-09-20

Results Overview

Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered.

• Recruitment status: COMPLETED
• Target enrollment: 1285 participants
• Primary outcome timeframe: From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)
• Results posted on: 2024-09-20

Participant Flow

Participants with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC) who were prescribed palbociclib in routine clinical practice across the United States and Canada were enrolled in this prospective observational study. Participants were followed up for approximately 3 years post end of treatment or until withdrawal from the study or death.

A total of 1285 participants were enrolled in the study. However, only 1250 participants initiated treatment with palbociclib.

Participant milestones

Measure	Palbociclib + Endocrine Therapy Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Overall Study STARTED	1250
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	1196

Reasons for withdrawal

Measure	Palbociclib + Endocrine Therapy Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Overall Study Death	505
Overall Study Study terminated by sponsor	383
Overall Study Other	148
Overall Study No longer willing to participate in study	101
Overall Study Lost to follow up	39
Overall Study Adverse Event	20

Baseline Characteristics

Palbociclib in Real World Practice

Baseline characteristics by cohort

Measure	Palbociclib + Endocrine Therapy n=1250 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Age, Continuous	63.0 Years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	1235 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1106 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=5 Participants
Race (NIH/OMB) Asian	23 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	139 Participants n=5 Participants
Race (NIH/OMB) White	1022 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)

Population: Safety analysis set included all participants enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Real world tumor response included complete response (CR), Partial response (PR), Stable disease (SD), Progressive Disease (PD), and was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. Response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria may not be available for all participants. rwTR was derived as the best tumor response recorded from the palbociclib combination treatment start date until the first documentation of progressive disease. Only response assessments recorded on or before the start date of next subsequent line of treatment will be considered.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=1250 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Number of Participants According to Real-World Tumor Response Overall · Complete response	72 Participants
Number of Participants According to Real-World Tumor Response Overall · Partial Response	310 Participants
Number of Participants According to Real-World Tumor Response Overall · Stable disease	499 Participants
Number of Participants According to Real-World Tumor Response Overall · Progressive disease	223 Participants
Number of Participants According to Real-World Tumor Response Overall · Indeterminate	146 Participants
Number of Participants According to Real-World Tumor Response 1 Line of treatment · Complete response	58 Participants
Number of Participants According to Real-World Tumor Response 1 Line of treatment · Partial Response	248 Participants
Number of Participants According to Real-World Tumor Response 1 Line of treatment · Stable disease	352 Participants
Number of Participants According to Real-World Tumor Response 1 Line of treatment · Progressive disease	144 Participants
Number of Participants According to Real-World Tumor Response 1 Line of treatment · Indeterminate	106 Participants
Number of Participants According to Real-World Tumor Response 2 or more lines of treatment · Complete response	14 Participants
Number of Participants According to Real-World Tumor Response 2 or more lines of treatment · Partial Response	62 Participants
Number of Participants According to Real-World Tumor Response 2 or more lines of treatment · Stable disease	147 Participants
Number of Participants According to Real-World Tumor Response 2 or more lines of treatment · Progressive disease	79 Participants
Number of Participants According to Real-World Tumor Response 2 or more lines of treatment · Indeterminate	40 Participants

PRIMARY outcome

Timeframe: From start of palbociclib combination treatment until first documentation of progression (up to approximately 3 years)

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Real world tumor response rate was defined as the percentage of participants with a best tumor response of complete response or partial response. Tumor response was determined by physician based on imaging, biopsies, biomarkers, and/or clinical judgment. RECIST criteria may not be available for all participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=1250 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Real-World Tumor Response Rate Overall	30.6 Percentage of participants Interval 28.0 to 33.2
Real-World Tumor Response Rate 1 Line of treatment	33.7 Percentage of participants Interval 30.6 to 36.9
Real-World Tumor Response Rate 2 or more lines of treatment	22.2 Percentage of participants Interval 17.9 to 27.0

PRIMARY outcome

Timeframe: From initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurs first. (up to approximately 3 years)

Population: Safety analysis set included all participants enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Real world progression free survival was defined as time (months) from initiation of the palbociclib combination treatment to the earliest of clinician-documented progression or death due to any cause, whichever occurred first. Participants without documented disease progression or death were censored at the last date of response assessment.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=1250 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Real World Progression Free Survival Overall	18.8 Months Interval 17.2 to 20.5
Real World Progression Free Survival 1 line of treatment	21.0 Months Interval 18.8 to 24.7
Real World Progression Free Survival 2 or more lines of treatment	13.2 Months Interval 10.4 to 16.8

PRIMARY outcome

Timeframe: From initiation of the palbociclib combination treatment to death due to any cause or censored, (up to approximately 3 years)

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.

Overall survival was defined as time from initiation of the palbociclib combination treatment to date of death due to any cause. Participants without a documented death were censored at last available visit date known to be alive.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=1250 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Overall Survival Overall	42.3 Months Interval 39.3 to 47.1
Overall Survival 1 line of treatment	48.5 Months Interval 42.0 to Upper limit of 95% CI could not be calculated due to insufficient number participants with the events.
Overall Survival 2 or more lines of treatment	37.2 Months Interval 31.2 to 40.8

PRIMARY outcome

Timeframe: Baseline (last observed measurement prior to treatment start date)

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=366 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Absolute Eastern Co-Operative Oncology Group (ECOG) Performance Status Scores at Baseline: Participants More Than or Equal to 70 Years Only	0.7 Units on a scale Standard Deviation 0.74

PRIMARY outcome

Timeframe: Month 1

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, Here 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=326 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 1: Participants More Than or Equal to 70 Years Only	0.7 Units on a scale Standard Deviation 0.73

PRIMARY outcome

Timeframe: Month 2

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, Here 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=294 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 2: Participants More Than or Equal to 70 Years Only	0.7 Units on a scale Standard Deviation 0.70

PRIMARY outcome

Timeframe: Month 3

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=297 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 3: Participants More Than or Equal to 70 Years Only	0.7 Units on a scale Standard Deviation 0.71

PRIMARY outcome

Timeframe: Month 6

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=275 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 6: Participants More Than or Equal to 70 Years Only	0.8 Units on a scale Standard Deviation 0.73

PRIMARY outcome

Timeframe: Month 9

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=224 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 9: Participants More Than or Equal to 70 Years Only	0.8 Units on a scale Standard Deviation 0.71

PRIMARY outcome

Timeframe: Month 12

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=193 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 12: Participants More Than or Equal to 70 Years Only	0.8 Units on a scale Standard Deviation 0.75

PRIMARY outcome

Timeframe: Month 15

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=165 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 15: Participants More Than or Equal to 70 Years Only	0.8 Units on a scale Standard Deviation 0.75

PRIMARY outcome

Timeframe: Month 18

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=116 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 18: Participants More Than or Equal to 70 Years Only	0.7 Units on a scale Standard Deviation 0.74

PRIMARY outcome

Timeframe: Month 21

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=80 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 21: Participants More Than or Equal to 70 Years Only	0.8 Units on a scale Standard Deviation 0.82

PRIMARY outcome

Timeframe: Month 24

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=67 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 24: Participants More Than or Equal to 70 Years Only	0.7 Units on a scale Standard Deviation 0.81

PRIMARY outcome

Timeframe: Month 27

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=41 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores in Month 27: Participants More Than or Equal to 70 Years Only	0.9 Units on a scale Standard Deviation 0.88

PRIMARY outcome

Timeframe: Month 30

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=25 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 30: Participants More Than or Equal to 70 Years Only	0.9 Units on a scale Standard Deviation 0.86

PRIMARY outcome

Timeframe: Month 33

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=11 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 33: Participants More Than or Equal to 70 Years Only	0.9 Units on a scale Standard Deviation 0.70

PRIMARY outcome

Timeframe: Month 36

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=7 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores in Month 36: Participants More Than or Equal to 70 Years Only	0.6 Units on a scale Standard Deviation 0.53

PRIMARY outcome

Timeframe: Month 39

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=5 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 39: Participants More Than or Equal to 70 Years Only	0.4 Units on a scale Standard Deviation 0.55

PRIMARY outcome

Timeframe: Month 42

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

ECOG performance status was a 6-level item used to assess the physical health of participants and ranged from 0 (fully active) to 5 (dead).

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=2 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
ECOG Performance Status Scores at Month 42: Participants More Than or Equal to 70 Years Only	0.5 Units on a scale Standard Deviation 0.71

PRIMARY outcome

Timeframe: Baseline (last observed measurement prior to treatment start date)

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=354 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Baseline: Participants More Than or Equal to 70 Years Only	13.4 Units on a scale Standard Deviation 2.24

PRIMARY outcome

Timeframe: Month 1

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=300 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 1: Participants More Than or Equal to 70 Years Only	13.3 Units on a scale Standard Deviation 2.23

PRIMARY outcome

Timeframe: Month 2

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=255 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 2: Participants More Than or Equal to 70 Years Only	13.4 Units on a scale Standard Deviation 2.36

PRIMARY outcome

Timeframe: Month 3

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=180 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 3: Participants More Than or Equal to 70 Years Only	13.4 Units on a scale Standard Deviation 2.20

PRIMARY outcome

Timeframe: Month 6

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=215 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 6: Participants More Than or Equal to 70 Years Only	13.5 Units on a scale Standard Deviation 2.05

PRIMARY outcome

Timeframe: Month 9

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=181 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 9: Participants More Than or Equal to 70 Years Only	13.7 Units on a scale Standard Deviation 1.90

PRIMARY outcome

Timeframe: Month 12

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=137 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 12: Participants More Than or Equal to 70 Years Only	13.7 Units on a scale Standard Deviation 1.97

PRIMARY outcome

Timeframe: Month 15

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=104 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 15: Participants More Than or Equal to 70 Years Only	13.6 Units on a scale Standard Deviation 2.06

PRIMARY outcome

Timeframe: Month 18

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=83 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 18: Participants More Than or Equal to 70 Years Only	13.4 Units on a scale Standard Deviation 2.26

PRIMARY outcome

Timeframe: Month 21

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=55 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 21: Participants More Than or Equal to 70 Years Only	13.4 Units on a scale Standard Deviation 1.70

PRIMARY outcome

Timeframe: Month 24

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=44 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 24: Participants More Than or Equal to 70 Years Only	13.5 Units on a scale Standard Deviation 2.33

PRIMARY outcome

Timeframe: Month 27

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=28 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 27: Participants More Than or Equal to 70 Years Only	13.3 Units on a scale Standard Deviation 2.17

PRIMARY outcome

Timeframe: Month 30

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=16 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 30: Participants More Than or Equal to 70 Years Only	13.1 Units on a scale Standard Deviation 1.98

PRIMARY outcome

Timeframe: Month 33

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=13 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 33: Participants More Than or Equal to 70 Years Only	13.3 Units on a scale Standard Deviation 1.89

PRIMARY outcome

Timeframe: Month 36

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=4 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 36: Participants More Than or Equal to 70 Years Only	14.1 Units on a scale Standard Deviation 1.44

PRIMARY outcome

Timeframe: Month 39

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=4 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 39: Participants More Than 70 or Equal to Years Only	13.5 Units on a scale Standard Deviation 2.65

PRIMARY outcome

Timeframe: Month 42

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

The G8 Screening Tool consisted of 7 items based on the Mini-Nutritional Assessment and a single item covering the participants age. Specifically, the G8 assessed food intake, weight changes, mobility, neuropsychological problems, body mass index, prescription count, and health status compared to similarly aged participants. Points were associated to each item and index score was calculated by summing points. The index score ranged in value from 0 (heavily impaired) to 17 (not at all impaired). If any of the 8 items was missing, the total score was missing.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=2 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Geriatric 8 Screening Tool Scores at Month 42: Participants More Than or Equal to 70 Years Only	13.0 Units on a scale Standard Deviation 1.41

PRIMARY outcome

Timeframe: Baseline (last observed measurement prior to treatment start date) and Month 6

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here 'Number Analyzed' signifies number of participants who provided an answer on the QoL Questionnaire for the specific item listed on each row.

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30: 30 item questionnaires composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=1250 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Nausea and vomiting	-1.7 Units on a scale Standard Deviation 20.9
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Global health status/QoL	3.5 Units on a scale Standard Deviation 22.5
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Dyspnoea	-1.9 Units on a scale Standard Deviation 27.7
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Insomnia	-0.9 Units on a scale Standard Deviation 32.8
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Appetite loss	-4.5 Units on a scale Standard Deviation 31.3
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Constipation	-1.7 Units on a scale Standard Deviation 29.1
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Diarrhoea	0.5 Units on a scale Standard Deviation 24.8
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Financial difficulties	-0.7 Units on a scale Standard Deviation 30.4
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Physical functioning	1.9 Units on a scale Standard Deviation 19.3
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Role functioning	4.2 Units on a scale Standard Deviation 31.5
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Emotional functioning	4.9 Units on a scale Standard Deviation 20.3
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Cognitive functioning	0.6 Units on a scale Standard Deviation 20.9
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Social functioning	3.9 Units on a scale Standard Deviation 27.2
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Fatigue	-0.7 Units on a scale Standard Deviation 25.0
Change From Baseline to Month 6 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Pain	-6.9 Units on a scale Standard Deviation 29.8

PRIMARY outcome

Timeframe: Baseline (last observed measurement prior to treatment start date) and Month 12

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here 'Number Analyzed' signifies number of participants who provided an answer on the QoL Questionnaire for the specific item listed on each row.

EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=1250 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Financial difficulties	-3.1 Units on a scale Standard Deviation 28.9
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Global health status/QoL	2.5 Units on a scale Standard Deviation 23.1
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Dyspnoea	-1.8 Units on a scale Standard Deviation 29.3
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Insomnia	-3.1 Units on a scale Standard Deviation 32.9
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Appetite loss	-5.1 Units on a scale Standard Deviation 32.1
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Constipation	-1.9 Units on a scale Standard Deviation 26.3
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Diarrhoea	0.1 Units on a scale Standard Deviation 23.5
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Physical functioning	1.2 Units on a scale Standard Deviation 20.0
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Role functioning	4.5 Units on a scale Standard Deviation 32.3
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Emotional functioning	4.7 Units on a scale Standard Deviation 20.4
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Cognitive functioning	0.1 Units on a scale Standard Deviation 21.5
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Social functioning	3.4 Units on a scale Standard Deviation 29.0
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Fatigue	-0.4 Units on a scale Standard Deviation 25.9
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Nausea and vomiting	-1.3 Units on a scale Standard Deviation 21.2
Change From Baseline to Month 12 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Pain	-5.7 Units on a scale Standard Deviation 30.2

PRIMARY outcome

Timeframe: Baseline (last observed measurement prior to treatment start date) and Month 18

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here 'Number Analyzed' signifies number of participants who provided an answer on the QoL Questionnaire for the specific item listed on each row.

EORTC QLQ-C30: 30 item questionnaire composed of 5 functional subscales (physical, role, cognitive, emotional, and social); a global health/global quality of life scale; 3 symptom subscales (fatigue, pain and nausea/vomiting); and 6 single items that assessed additional symptoms (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). All scales and single item measures ranged in score from 0 to 100. Higher scores on functional and global quality of life scales represent better level of functioning. Higher scores on the symptom oriented scales represent more severe symptoms.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=1250 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Global health status/QoL	2.5 Units on a scale Standard Deviation 24.5
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Dyspnoea	0.4 Units on a scale Standard Deviation 28.3
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Insomnia	-3.5 Units on a scale Standard Deviation 32.8
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Appetite loss	-4.7 Units on a scale Standard Deviation 31.7
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Constipation	-1.4 Units on a scale Standard Deviation 30.3
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Diarrhoea	0.8 Units on a scale Standard Deviation 26.9
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Financial difficulties	-2.5 Units on a scale Standard Deviation 30.9
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Physical functioning	1.6 Units on a scale Standard Deviation 21.6
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Role functioning	6.0 Units on a scale Standard Deviation 33.7
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Emotional functioning	5.9 Units on a scale Standard Deviation 19.4
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Cognitive functioning	-0.9 Units on a scale Standard Deviation 22.2
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Social functioning	4.8 Units on a scale Standard Deviation 28.9
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Fatigue	-1.8 Units on a scale Standard Deviation 26.0
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Nausea and vomiting	-2.2 Units on a scale Standard Deviation 22.1
Change From Baseline to Month 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scores at Baseline Pain	-7.6 Units on a scale Standard Deviation 31.8

PRIMARY outcome

Timeframe: Baseline (last observed measurement prior to treatment start date)

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=365 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Baseline: Participants More Than or Equal to 70 Years Only	17.6 Units on a scale Standard Deviation 1.14

PRIMARY outcome

Timeframe: Month 1

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=313 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 1: Participants More Than or Equal to 70 Years Only	17.6 Units on a scale Standard Deviation 1.23

PRIMARY outcome

Timeframe: Month 2

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=269 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 2: Participants More Than or Equal to 70 Years Only	17.7 Units on a scale Standard Deviation 1.08

PRIMARY outcome

Timeframe: Month 3

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=193 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 3: Participants More Than or Equal to 70 Years Only	17.6 Units on a scale Standard Deviation 1.00

PRIMARY outcome

Timeframe: Month 6

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=228 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores Month 6: Participants More Than or Equal to 70 Years Only	17.6 Units on a scale Standard Deviation 1.19

PRIMARY outcome

Timeframe: Month 9

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=185 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 9: Participants More Than or Equal to 70 Years Only	17.6 Units on a scale Standard Deviation 1.47

PRIMARY outcome

Timeframe: Month 12

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=140 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 12: Participants More Than or Equal to 70 Years Only	17.4 Units on a scale Standard Deviation 1.55

PRIMARY outcome

Timeframe: Month 15

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=112 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 15: Participants More Than or Equal to 70 Years Only	17.5 Units on a scale Standard Deviation 1.52

PRIMARY outcome

Timeframe: Month 18

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participant.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=85 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 18: Participants More Than or Equal to 70 Years Only	17.6 Units on a scale Standard Deviation 1.13

PRIMARY outcome

Timeframe: Month 21

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=57 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 21: Participants More Than or Equal to 70 Years Only	17.7 Units on a scale Standard Deviation 0.91

PRIMARY outcome

Timeframe: Month 24

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication.'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=48 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 24: Participants More Than or Equal to 70 Years Only	17.6 Units on a scale Standard Deviation 0.93

PRIMARY outcome

Timeframe: Month 27

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=27 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 27: Participants More Than or Equal to 70 Years Only	17.5 Units on a scale Standard Deviation 1.01

PRIMARY outcome

Timeframe: Month 30

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=16 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 30: Participants More Than or Equal to 70 Years Only	17.3 Units on a scale Standard Deviation 2.05

PRIMARY outcome

Timeframe: Month 33

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=13 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 33: Participants More Than or Equal to 70 Years Only	17.5 Units on a scale Standard Deviation 1.66

PRIMARY outcome

Timeframe: Month 36

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=4 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 36: Participants More Than or Equal to 70 Years Only	17.3 Units on a scale Standard Deviation 1.50

PRIMARY outcome

Timeframe: Month 39

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=4 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 39: Participants More Than or Equal to 70 Years Only	17.3 Units on a scale Standard Deviation 1.50

PRIMARY outcome

Timeframe: Month 42

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication, 'Overall Number of Participants Analyzed' signifies participants evaluable for the outcome measure.

Activities of Daily Living is assessed using a six-item ADL limitations measure that inventoried whether participants had difficulty bathing, dressing, toileting, feeding, with transfer, and incontinence. Each item was rated on a 3-point Likert scale measuring independence in performing the activity and scores ranged from 1 to 3; where, 1=unable to do without assistance, 2=partial assistance needed and 3=no assistance. The total score was calculated as a sum of scores of individual items and ranged between 6 to 18, where a score of 6 indicated a very dependent participant and a score of 18 represented an independent participants.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=2 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Activities of Daily Living Scores at Month 42: Participants More Than or Equal to 70 Years Only	16.5 Units on a scale Standard Deviation 2.12

PRIMARY outcome

Timeframe: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years)

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication.

An adverse event is any untoward medical occurrence in administered medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=1250 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Number of Participants With Adverse Events	1123 Participants

PRIMARY outcome

Timeframe: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication.

A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=1250 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Number of Participants With Serious Adverse Events	403 Participants

PRIMARY outcome

Timeframe: From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years).

Population: Safety analysis set included all participants who were enrolled in the study and received at least one dose of study medication.

Following lab parameters were assessed Anemia, Hemoglobin increased, Lymphocyte count decreased, Lymphocyte count increased, Neutrophil count decreased, Platelet count decreased, Leukocyte count decreased, Leukocyte count increased, Number of participants with any lab abnormality was reported.

Outcome measures

Measure	Palbociclib + Endocrine Therapy n=1250 Participants Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Number of Participants With Any Clinical Laboratory Abnormalities	1170 Participants

Adverse Events

Palbociclib + Endocrine Therapy

Serious events: 403 serious events

Other events: 1035 other events

Deaths: 505 deaths

Serious adverse events

Measure	Palbociclib + Endocrine Therapy n=1250 participants at risk Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Blood and lymphatic system disorders Neutropenia	0.32% 4/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Blood and lymphatic system disorders Anaemia	1.4% 18/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Blood and lymphatic system disorders Leukopenia	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.48% 6/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Blood and lymphatic system disorders Febrile neutropenia	0.64% 8/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Blood and lymphatic system disorders Pancytopenia	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Blood and lymphatic system disorders Leukocytosis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Neutrophil count decreased	0.40% 5/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations White blood cell count decreased	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Platelet count decreased	0.40% 5/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Transaminases increased	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Blood creatinine increased	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Blood creatine increased	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Blood lactate dehydrogenase increased	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Respiratory syncytial virus test positive	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Weight decreased	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Sepsis	1.8% 22/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Pneumonia	1.6% 20/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Urinary tract infection	1.2% 15/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Cellulitis	0.72% 9/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Septic shock	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Appendicitis	0.32% 4/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Influenza	0.32% 4/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Bronchitis	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Diverticulitis	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Kidney infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Wound infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Abscess	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Bacteraemia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Clostridium difficile colitis	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Empyema	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Postoperative wound infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Pyelonephritis	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Urosepsis	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Beta haemolytic streptococcal infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Breast cellulitis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Corona virus infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Gastroenteritis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Liver abscess	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Lung infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Neutropenic sepsis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Osteomyelitis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Pneumonia viral	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Post procedural infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Pyelonephritis acute	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Staphylococcal bacteraemia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Subcutaneous abscess	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Tooth infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Upper respiratory tract infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Disease progression	2.9% 36/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Fatigue	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Asthenia	0.96% 12/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Death	0.56% 7/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Pain	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Chest pain	0.48% 6/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Pyrexia	0.64% 8/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Oedema peripheral	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Non-cardiac chest pain	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Hernia obstructive	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Systemic inflammatory response syndrome	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.1% 14/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.0% 13/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.96% 12/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.0% 13/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.48% 6/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.56% 7/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.40% 5/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Nausea	1.6% 20/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Vomiting	1.9% 24/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	0.72% 9/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	0.80% 10/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	0.72% 9/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Ascites	0.32% 4/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Dysphagia	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Intestinal obstruction	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain upper	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Colitis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Obstruction gastric	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Oesophagitis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Toothache	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Abdominal distension	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Abdominal hernia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Constipation	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Enteritis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Enterocolitis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Gastric antral vascular ectasia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Gastric haemorrhage	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Gastrointestinal perforation	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Ileus	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Intestinal perforation	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Large intestinal obstruction	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Peptic ulcer	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Proctitis	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Rectal haemorrhage	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	1.8% 23/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.64% 8/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory carcinoma of the breast	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Dehydration	0.88% 11/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	0.32% 4/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.32% 4/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.56% 7/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Decreased appetite	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Hypercalcaemia	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Hyperphosphataemia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Failure to thrive	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Metabolic acidosis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Hypovolaemia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Lactic acidosis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Syncope	0.40% 5/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Headache	0.40% 5/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Cerebrovascular accident	0.64% 8/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Ischaemic stroke	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Metabolic encephalopathy	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Aphasia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Dizziness	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Encephalopathy	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Brain oedema	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Cerebral artery occlusion	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Cerebral haemorrhage	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Cerebral infarction	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Cerebrovascular disorder	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Cognitive disorder	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Dementia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Presyncope	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Seizure	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.32% 4/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	0.32% 4/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Pain in jaw	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Cardiac arrest	0.56% 7/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Atrial fibrillation	0.80% 10/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Cardiac failure congestive	0.64% 8/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Acute myocardial infarction	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Pericardial effusion	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Angina pectoris	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Cardiomyopathy	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Arrhythmia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Atrial flutter	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Atrioventricular block complete	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Cardiac failure chronic	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Cardio-respiratory arrest	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Cardiogenic shock	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Chronic left ventricular failure	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Left ventricular failure	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Supraventricular tachycardia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Fall	0.72% 9/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Hip fracture	0.32% 4/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Femur fracture	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Humerus fracture	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications fracture	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Compression fracture	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Craniocerebral injury	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Hand fracture	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Joint dislocation	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Overdose	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Radiation oesophagitis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Alcohol poisoning	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Vascular access complication	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Injury, poisoning and procedural complications Wound dehiscence	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Renal and urinary disorders Acute kidney injury	1.3% 16/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Renal and urinary disorders Hydronephrosis	0.32% 4/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Renal and urinary disorders Nephrolithiasis	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Renal and urinary disorders Haematuria	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Renal and urinary disorders Renal failure	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Renal and urinary disorders Renal tubular necrosis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Renal and urinary disorders Urinary tract obstruction	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Psychiatric disorders Depression	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Psychiatric disorders Confusional state	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Psychiatric disorders Mental status changes	0.40% 5/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Psychiatric disorders Hallucination	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Psychiatric disorders Anxiety	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Psychiatric disorders Psychotic disorder	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Psychiatric disorders Substance abuse	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Vascular disorders Hypotension	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Vascular disorders Deep vein thrombosis	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Vascular disorders Lymphoedema	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Vascular disorders Thrombophlebitis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Vascular disorders Hypovolaemic shock	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Vascular disorders Thrombophlebitis superficial	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Vascular disorders Vena cava thrombosis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Hepatobiliary disorders Hepatic failure	0.32% 4/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Hepatobiliary disorders Acute hepatic failure	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Hepatobiliary disorders Bile duct stone	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Hepatobiliary disorders Portal vein thrombosis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Eye disorders Diplopia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Eye disorders Exophthalmos	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Ear and labyrinth disorders Vertigo	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Immune system disorders Anaphylactic reaction	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Reproductive system and breast disorders Vaginal haemorrhage	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Left ventricular dysfunction	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Bradycardia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Palpitations	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Sinus arrest	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Tachycardia	0.24% 3/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Chest discomfort	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Medical device site joint infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Respiratory tract infection	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Occult blood positive	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Haemorrhage intracranial	0.16% 2/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Hypoaesthesia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Lacunar infarction	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Paraesthesia	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Aspartate aminotransferase increased	5.3% 66/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Cardiac disorders Cardiac Failure	0.08% 1/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.

Other adverse events

Measure	Palbociclib + Endocrine Therapy n=1250 participants at risk Participants with HR+/HER2- advanced breast cancer who were prescribed palbociclib in combination with endocrine treatment (Palbociclib, Fulvestrant, and Other) by the treating physician in routine clinical practice were included.
Blood and lymphatic system disorders Neutropenia	33.2% 415/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Blood and lymphatic system disorders Anaemia	24.8% 310/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	9.0% 112/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Nausea	24.6% 308/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	18.6% 233/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Constipation	10.6% 133/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Vomiting	9.4% 117/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Gastrointestinal disorders Stomatitis	8.2% 102/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
General disorders Fatigue	35.5% 444/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations White blood cell count decreased	21.8% 272/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Neutrophil count decreased	22.7% 284/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Platelet count decreased	12.9% 161/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Lymphocyte count decreased	9.3% 116/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	16.2% 202/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	12.0% 150/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 89/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Headache	10.2% 128/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Dizziness	8.4% 105/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Nervous system disorders Neuropathy peripheral	5.4% 68/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 125/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	8.6% 107/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Skin and subcutaneous tissue disorders Alopecia	9.0% 113/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Vascular disorders Hot flush	9.8% 123/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Metabolism and nutrition disorders Decreased appetite	9.8% 123/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Psychiatric disorders Insomnia	7.6% 95/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Infections and infestations Urinary tract infection	6.2% 78/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Blood and lymphatic system disorders Leukopenia	5.3% 66/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.
Investigations Aspartate aminotransferase increased	5.3% 66/1250 • From start of palbociclib treatment or date of informed consent until 28 days after last dose of study treatment (up to approximately 3 years) Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants enrolled in the study and received at least one dose of study medication.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER