Trial Outcomes & Findings for Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer (NCT NCT02785939)

NCT ID: NCT02785939

Last Updated: 2021-05-27

Results Overview

The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with palbociclib per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR It was pre-specified that only the palbociclib arm would be analyzed due to removal of docetaxel as standard of care treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 53 participants
• Primary outcome timeframe: From date of registration to progression or treatment discontinuation, up to 2 years and 10 months.
• Results posted on: 2021-05-27

Participant Flow

36 participants were initially enrolled to Palbociclib arm and 17 to Docetaxel. 5 participants on Palbociclib were ineligible. 5 participants on Docetaxel were ineligible, and 2 did not receive any protocol treatment. A participant on Docetaxel was re-registered to Palbociclib after progression on Docetaxel and is also included in Palbociclib arm analysis.

Participant milestones

Measure	Palbociclib Participants receive Palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Palbociclib: Given PO	Docetaxel Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to Palbociclib. Given IV (arm II closed to accrual 12/18/2015) Other Names: •Docecad * Docetaxel * RP56976 * Taxotere * Taxotere Injection Concentrate Laboratory Biomarker Analysis Correlative studies
Overall Study STARTED	31	10
Overall Study Participants Re-registered to Palbociclib After Progression on Docetaxel	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	31	10

Reasons for withdrawal

Measure	Palbociclib Participants receive Palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Palbociclib: Given PO	Docetaxel Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to Palbociclib. Given IV (arm II closed to accrual 12/18/2015) Other Names: •Docecad * Docetaxel * RP56976 * Taxotere * Taxotere Injection Concentrate Laboratory Biomarker Analysis Correlative studies
Overall Study Progression	25	8
Overall Study Adverse Event	3	1
Overall Study Death	1	0
Overall Study Refusal	1	0
Overall Study Deteriorating health	1	0
Overall Study Not protocol specified	0	1

Baseline Characteristics

Docetaxel arm closed before data were collected

Baseline characteristics by cohort

Measure	Palbociclib n=31 Participants Participants receive Palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Palbociclib: Given PO	Docetaxel n=10 Participants Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to Palbociclib. Given IV (arm II closed to accrual 12/18/2015) Other Names: •Docecad * Docetaxel * RP56976 * Taxotere * Taxotere Injection Concentrate Laboratory Biomarker Analysis Correlative studies	Total n=41 Participants Total of all reporting groups
Age, Continuous	67.6 years n=31 Participants	61.8 years n=10 Participants	64.9 years n=41 Participants
Sex: Female, Male Female	11 Participants n=31 Participants	3 Participants n=10 Participants	14 Participants n=41 Participants
Sex: Female, Male Male	20 Participants n=31 Participants	7 Participants n=10 Participants	27 Participants n=41 Participants
Race/Ethnicity, Customized Asian	1 Participants n=31 Participants	0 Participants n=10 Participants	1 Participants n=41 Participants
Race/Ethnicity, Customized Black	3 Participants n=31 Participants	0 Participants n=10 Participants	3 Participants n=41 Participants
Race/Ethnicity, Customized Native American	0 Participants n=31 Participants	1 Participants n=10 Participants	1 Participants n=41 Participants
Race/Ethnicity, Customized White	27 Participants n=31 Participants	9 Participants n=10 Participants	36 Participants n=41 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=31 Participants	0 Participants n=10 Participants	0 Participants n=41 Participants
Performance status 0	12 Participants n=31 Participants	3 Participants n=10 Participants	15 Participants n=41 Participants
Performance status 1	18 Participants n=31 Participants	6 Participants n=10 Participants	24 Participants n=41 Participants
Performance status 2	1 Participants n=31 Participants	1 Participants n=10 Participants	2 Participants n=41 Participants
Number of prior lines of therapy 0	8 Participants n=31 Participants • Docetaxel arm closed before data were collected	—	8 Participants n=31 Participants • Docetaxel arm closed before data were collected
Number of prior lines of therapy 1	22 Participants n=31 Participants • Docetaxel arm closed before data were collected	—	22 Participants n=31 Participants • Docetaxel arm closed before data were collected
Number of prior lines of therapy >=2	1 Participants n=31 Participants • Docetaxel arm closed before data were collected	—	1 Participants n=31 Participants • Docetaxel arm closed before data were collected
Smoking status Current smoker	13 Participants n=31 Participants	2 Participants n=10 Participants	15 Participants n=41 Participants
Smoking status Former smoker	17 Participants n=31 Participants	8 Participants n=10 Participants	25 Participants n=41 Participants
Smoking status Never-smoker	1 Participants n=31 Participants	0 Participants n=10 Participants	1 Participants n=41 Participants
Brain metastases Present	2 Participants n=31 Participants	0 Participants n=10 Participants	2 Participants n=41 Participants
Brain metastases Absent	29 Participants n=31 Participants	10 Participants n=10 Participants	39 Participants n=41 Participants

PRIMARY outcome

Timeframe: From date of registration to progression or treatment discontinuation, up to 2 years and 10 months.

Population: Eligible and evaluable participants.

The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with palbociclib per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

It was pre-specified that only the palbociclib arm would be analyzed due to removal of docetaxel as standard of care treatment

Outcome measures

Measure	Palbociclib n=32 Participants Participants receive Palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Palbociclib: Given PO
Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial)	6 percentage of participants Interval 0.0 to 15.0

SECONDARY outcome

Timeframe: From date of registration to maximum of 2 years and 10 months or death

Population: Evaluable and eligible participants that achieved complete or partial response. 1 participant died without evidence of progression at 12 months.

From date of first documentation of response (complete or partial) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among participants who achieve a complete or partial response.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

It was pre-specified that only the palbociclib arm would be analyzed due to removal of docetaxel as standard of care treatment

Outcome measures

Measure	Palbociclib n=2 Participants Participants receive Palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Palbociclib: Given PO
Duration of Response Among Participants Who Achieve a Complete Response or Partial Response by Response Evaluation Criteria in Solid Tumors 1.1	10.0 months Interval 7.7 to 12.0

SECONDARY outcome

Timeframe: From date of registration to maximum of 2 years and 10 months or death

Population: Eligible and evaluable participants

From date of sub-study registration until death due to any cause.

It was pre-specified that only the palbociclib arm would be analyzed due to removal of docetaxel as standard of care treatment

Outcome measures

Measure	Palbociclib n=32 Participants Participants receive Palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Palbociclib: Given PO
Overall Survival With Investigational Therapy	7.1 months Interval 4.2 to 12.5

SECONDARY outcome

Timeframe: From date of registration to maximum of 2 years and 10 months or death

Population: Eligible and evaluable participants

From date of sub-study registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.

It was pre-specified that only the palbociclib arm would be analyzed due to removal of docetaxel as standard of care treatment

Outcome measures

Measure	Palbociclib n=32 Participants Participants receive Palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Palbociclib: Given PO
Progression-free Survival With Palbociclib.	1.7 months Interval 1.6 to 2.9

SECONDARY outcome

Timeframe: Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death

Population: Participants who received at least one dose of palbociclib treatment.

Adverse Events (AEs) are reported per CTCAE Version 5.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

It was pre-specified that only the palbociclib arm would be analyzed due to removal of docetaxel as standard of care treatment

Outcome measures

Measure	Palbociclib n=32 Participants Participants receive Palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Palbociclib: Given PO
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neutrophil count decreased	5 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Platelet count decreased	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs White blood cell decreased	6 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anemia	4 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anorexia	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Aspartate aminotransferase increased	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dyspnea	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fatigue	5 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Febrile neutropenia	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Generalized muscle weakness	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyperglycemia	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyponatremia	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypotension	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lung infection	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lymphocyte count decreased	9 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neoplasms benign, malignant & unspecified-Other	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Screen success rate is defined as the percentage of screened patients that register for a therapeutic sub-study. Screen success rates will be evaluated for the total screened population and by the subset of patients screened following progression on previous therapy or pre-screened on current therapy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Treatment arm randomization acceptance rate within each treatment arm of each randomized sub-study is defined as the ratio of the number of patients who receive any protocol treatment over the number that are randomized to that sub-study treatment arm.

Outcome measures

Outcome data not reported

Adverse Events

Palbociclib

Serious events: 14 serious events

Other events: 31 other events

Deaths: 28 deaths

Docetaxel

Serious events: 0 serious events

Other events: 10 other events

Deaths: 10 deaths

Serious adverse events

Measure	Palbociclib n=32 participants at risk Participants receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Palbociclib: Given PO	Docetaxel n=10 participants at risk Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to Palbociclib. Given IV (arm II closed to accrual 12/18/2015) Other Names: •Docecad * Docetaxel * RP56976 * Taxotere * Taxotere Injection Concentrate Laboratory Biomarker Analysis Correlative studies
Blood and lymphatic system disorders Anemia	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Blood and lymphatic system disorders Febrile neutropenia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Edema limbs	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Fatigue	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Fever	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Infections and infestations Lung infection	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Infections and infestations Upper respiratory infection	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Injury, poisoning and procedural complications Wound complication	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Aspartate aminotransferase increased	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations INR increased	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Lymphocyte count decreased	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Neutrophil count decreased	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Platelet count decreased	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations White blood cell decreased	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Anorexia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Hypercalcemia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Hyponatremia	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Nervous system disorders Seizure	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Nervous system disorders Syncope	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Nervous system disorders Transient ischemic attacks	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Renal and urinary disorders Chronic kidney disease	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Renal and urinary disorders Urinary retention	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Dyspnea	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Hypoxia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Productive cough	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Resp, thoracic and mediastinal disorders - Other	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Vascular disorders Hypotension	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0

Other adverse events

Measure	Palbociclib n=32 participants at risk Participants receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Palbociclib: Given PO	Docetaxel n=10 participants at risk Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to Palbociclib. Given IV (arm II closed to accrual 12/18/2015) Other Names: •Docecad * Docetaxel * RP56976 * Taxotere * Taxotere Injection Concentrate Laboratory Biomarker Analysis Correlative studies
Blood and lymphatic system disorders Anemia	59.4% 19/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	70.0% 7/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Blood and lymphatic system disorders Febrile neutropenia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Cardiac disorders Atrial fibrillation	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	30.0% 3/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Cardiac disorders Palpitations	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Cardiac disorders Sinus tachycardia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Cardiac disorders Ventricular tachycardia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Ear and labyrinth disorders Ear pain	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Ear and labyrinth disorders Hearing impaired	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Eye disorders Blurred vision	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Eye disorders Conjunctivitis	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Eye disorders Dry eye	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Eye disorders Eye disorders-Other	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Eye disorders Eye pain	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Abdominal pain	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Bloating	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Constipation	21.9% 7/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Diarrhea	12.5% 4/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	50.0% 5/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Dry mouth	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Dyspepsia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Dysphagia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Flatulence	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Gastroesophageal reflux disease	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Mucositis oral	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	30.0% 3/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Nausea	34.4% 11/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	40.0% 4/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Gastrointestinal disorders Vomiting	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Chills	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Edema face	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Edema limbs	15.6% 5/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Edema trunk	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Fatigue	56.2% 18/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	60.0% 6/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Fever	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Flu like symptoms	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders General disorders and admin site conditions - Other	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Infusion related reaction	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Malaise	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Non-cardiac chest pain	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
General disorders Pain	18.8% 6/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Immune system disorders Allergic reaction	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Infections and infestations Bronchial infection	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Infections and infestations Infections and infestations-Other	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Infections and infestations Lung infection	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Infections and infestations Sepsis	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Infections and infestations Upper respiratory infection	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Infections and infestations Urinary tract infection	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Injury, poisoning and procedural complications Bruising	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Injury, poisoning and procedural complications Fall	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Alanine aminotransferase increased	12.5% 4/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Alkaline phosphatase increased	25.0% 8/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Aspartate aminotransferase increased	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Blood bilirubin increased	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Creatinine increased	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations INR increased	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Investigations-Other	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Lymphocyte count decreased	43.8% 14/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	30.0% 3/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Neutrophil count decreased	46.9% 15/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Platelet count decreased	37.5% 12/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations Weight loss	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Investigations White blood cell decreased	62.5% 20/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Anorexia	28.1% 9/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Dehydration	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	40.0% 4/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Glucose intolerance	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Hyperglycemia	18.8% 6/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	40.0% 4/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Hyperkalemia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Hypermagnesemia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Hypoalbuminemia	25.0% 8/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	50.0% 5/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Hypocalcemia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Hypokalemia	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Hypomagnesemia	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Hyponatremia	31.2% 10/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Back pain	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Bone pain	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Buttock pain	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Generalized muscle weakness	12.5% 4/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	40.0% 4/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tiss disorder - Other	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Myalgia	18.8% 6/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Nervous system disorders Dizziness	12.5% 4/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	40.0% 4/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Nervous system disorders Dysgeusia	12.5% 4/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Nervous system disorders Facial muscle weakness	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Nervous system disorders Headache	12.5% 4/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Nervous system disorders Paresthesia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Nervous system disorders Peripheral sensory neuropathy	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Psychiatric disorders Confusion	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Psychiatric disorders Depression	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Psychiatric disorders Hallucinations	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Psychiatric disorders Insomnia	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	30.0% 3/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Psychiatric disorders Restlessness	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Renal and urinary disorders Acute kidney injury	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Renal and urinary disorders Urinary frequency	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Renal and urinary disorders Urinary retention	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Cough	15.6% 5/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	30.0% 3/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Dyspnea	34.4% 11/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	50.0% 5/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 4/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Hypoxia	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Productive cough	9.4% 3/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Resp, thoracic and mediastinal disorders - Other	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Sore throat	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Respiratory, thoracic and mediastinal disorders Wheezing	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Skin and subcutaneous tissue disorders Alopecia	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	50.0% 5/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Skin and subcutaneous tissue disorders Dry skin	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Skin and subcutaneous tissue disorders Nail discoloration	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Skin and subcutaneous tissue disorders Pruritus	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Skin and subcutaneous tissue disorders Rash maculo-papular	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	0.00% 0/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	20.0% 2/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Vascular disorders Hypertension	3.1% 1/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	10.0% 1/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0
Vascular disorders Hypotension	6.2% 2/32 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0	30.0% 3/10 • Duration of treatment and follow up to a maximum of 2 years and 10 months post registration or death 41 participants were assessed for AEs: 32 on palbociclib and 10 on docetaxel arm. 1 participant that was re-registered from the docetaxel arm to receive palbociclib after progression was assessed for AEs in both arms. Adverse Events (AEs) are reported per CTCAE Version 5.0

Additional Information

Lung Committee Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: kmini@fredhutch.org

Results disclosure agreements

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