Trial Outcomes & Findings for Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer (NCT NCT02679755)

NCT ID: NCT02679755

Last Updated: 2022-07-27

Results Overview

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as treatment emergent adverse events (TEAEs). AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 252 participants
• Primary outcome timeframe: Baseline up to 28 days after last dose of study treatment, an average of 14 months
• Results posted on: 2022-07-27

Participant Flow

252 participants were assigned to treatment at 20 sites in India and Australia (100 in India, 152 in Australia)

Participant milestones

Measure	Palbociclib+Letrozole India Cohort Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Overall Study STARTED	100	152
Overall Study COMPLETED	66	47
Overall Study NOT COMPLETED	34	105

Reasons for withdrawal

Measure	Palbociclib+Letrozole India Cohort Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Overall Study Death	0	3
Overall Study Global deterioration of health status	1	8
Overall Study Lost to Follow-up	1	0
Overall Study Objective progression or relapse	24	83
Overall Study Not defined	0	2
Overall Study Withdrawal by participant	6	3
Overall Study Adverse Event	1	4
Overall Study Adverse events not related to study drug	1	2

Baseline Characteristics

Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

Baseline characteristics by cohort

Measure	Palbociclib+Letrozole India Cohort n=100 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=152 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Total n=252 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=5 Participants	107 Participants n=7 Participants	178 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	45 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	152 Participants n=7 Participants	252 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	100 Participants n=5 Participants	12 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	130 Participants n=7 Participants	130 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 28 days after last dose of study treatment, an average of 14 months

Population: The analysis population included all participants who received at least 1 dose of palbociclib treatment.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as treatment emergent adverse events (TEAEs). AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Measure	Palbociclib+Letrozole India Cohort n=100 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=152 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+LetrozoleTotal n=252 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Number of Participants With Treatment-Emergent Adverse Events (All Causalities) Participants with adverse events	92 Participants	152 Participants	244 Participants
Number of Participants With Treatment-Emergent Adverse Events (All Causalities) Participants with serious adverse events	18 Participants	45 Participants	63 Participants
Number of Participants With Treatment-Emergent Adverse Events (All Causalities) Participants with grade 3 or 4 adverse events	69 Participants	124 Participants	193 Participants
Number of Participants With Treatment-Emergent Adverse Events (All Causalities) Participants with grade 5 adverse events	3 Participants	7 Participants	10 Participants
Number of Participants With Treatment-Emergent Adverse Events (All Causalities) Participants discontinued due to adverse events	2 Participants	9 Participants	11 Participants

PRIMARY outcome

Timeframe: Baseline up to 28 days after last dose of study treatment, an average of 14 months

Population: The analysis population included all participants who received at least 1 dose of palbociclib treatment.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.

Outcome measures

Measure	Palbociclib+Letrozole India Cohort n=100 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=152 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+LetrozoleTotal n=252 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities) Grade 4	17 Participants	13 Participants	30 Participants
Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities) Grade 1	7 Participants	11 Participants	18 Participants
Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities) Grade 2	16 Participants	16 Participants	32 Participants
Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities) Grade 3	49 Participants	105 Participants	154 Participants
Number of Participants With Treatment-Emergent Adverse Events by Severity (All Causalities) Grade 5	3 Participants	7 Participants	10 Participants

PRIMARY outcome

Timeframe: Baseline up to 28 days after last dose of study treatment, an average of 14 months

Population: The analysis population included all participants who received at least 1 dose of palbociclib treatment.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Palbociclib-related TEAEs were determined by the investigator.

Outcome measures

Measure	Palbociclib+Letrozole India Cohort n=100 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=152 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+LetrozoleTotal n=252 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related) Participants discontinued due to adverse events	1 Participants	4 Participants	5 Participants
Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related) Participants with adverse events	80 Participants	143 Participants	223 Participants
Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related) Participants with serious adverse events	8 Participants	12 Participants	20 Participants
Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related) Participants with grade 3 or 4 adverse events	64 Participants	108 Participants	172 Participants
Number of Participants With Treatment-Emergent Adverse Events (Palbociclib-Related) Participants with grade 5 adverse events	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline up to 28 days after last dose of study treatment, an average of 14 months

Population: The analysis population included all participants who received at least 1 dose of palbociclib treatment.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as TEAE. AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. Palbociclib-related TEAEs were determined by the investigator.

Outcome measures

Measure	Palbociclib+Letrozole India Cohort n=100 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=152 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+LetrozoleTotal n=252 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related) Grade 1	6 Participants	21 Participants	27 Participants
Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related) Grade 2	10 Participants	14 Participants	24 Participants
Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related) Grade 3	49 Participants	93 Participants	142 Participants
Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related) Grade 4	15 Participants	14 Participants	29 Participants
Number of Participants With Treatment-Emergent Adverse Events by Severity (Palbociclib-Related) Grade 5	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline up to 28 days after last dose of study treatment, an average of 14 months

Population: The analysis population included all participants who received at least 1 dose of palbociclib treatment.

An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Palbociclib-related SAEs were determined by the investigator.

Outcome measures

Measure	Palbociclib+Letrozole India Cohort n=100 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=152 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+LetrozoleTotal n=252 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Number of Participants With Serious Adverse Events (All Causalities and Palbociclib-Related) All-causality	18 Participants	45 Participants	63 Participants
Number of Participants With Serious Adverse Events (All Causalities and Palbociclib-Related) Palciclib-Related	8 Participants	12 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year

Population: The analysis population included participants with efficacy data contributing to the analysis

Tumor response assessments were evaluated as per local guidelines by investigators and were collected in the CRF. No response confirmation was applied.

Outcome measures

Measure	Palbociclib+Letrozole India Cohort n=100 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=152 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+LetrozoleTotal n=252 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Percentage of Participants With Complete Response and Partial Response Percentage of participants with complete response	1.0 Percentage of evaluable participants	1.3 Percentage of evaluable participants	1.2 Percentage of evaluable participants
Percentage of Participants With Complete Response and Partial Response Percentage of participants with partial response	28.0 Percentage of evaluable participants	11.8 Percentage of evaluable participants	18.3 Percentage of evaluable participants

SECONDARY outcome

Timeframe: Baseline and per routine clinical practice to time of last dose of study treatment, an average of 1 year

Population: The analysis population included participants with efficacy data contributing to the analysis

The tumor response was based on the response reported by investigator per local practice. No response confirmation was applied. ORR was defined as the percentage of participants with complete response or partial response relative to all as-treated population.

Outcome measures

Measure	Palbociclib+Letrozole India Cohort n=100 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=152 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+LetrozoleTotal n=252 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
The Objective Response Rate (ORR)	29.0 Percentage of evaluable participants Interval 20.4 to 38.9	13.2 Percentage of evaluable participants Interval 8.2 to 19.6	19.4 Percentage of evaluable participants Interval 14.7 to 24.9

SECONDARY outcome

Timeframe: The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline.

Population: Patient reported outcome (PRO)-evaluable population was only consisted of the Australia cohort

The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The first part was a 5 item questionnaire designed to assess health status in terms of a single index value or utility score. It consisted of 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). A respondent was asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/impairment. The answers given to the 5 descriptors permit to find 243 unique health states which can be converted into a single EQ-5D index value by published algorithms. For the EQ-5D index, published weights are available that allow for the creation of a summary score ranging from -0.594 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health.

Outcome measures

Measure	Palbociclib+Letrozole India Cohort Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=146 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+LetrozoleTotal Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
EQ-5D Health Utility Index Score End of Study (EOS)	—	0.770 Scores on a scale Standard Deviation 0.247	—
EQ-5D Health Utility Index Score Cycle 1 Day 1	—	0.786 Scores on a scale Standard Deviation 0.171	—
EQ-5D Health Utility Index Score Cycle 2 Day 1	—	0.798 Scores on a scale Standard Deviation 0.187	—
EQ-5D Health Utility Index Score Cycle 3 Day 1	—	0.798 Scores on a scale Standard Deviation 0.169	—
EQ-5D Health Utility Index Score Cycle 4 Day 1	—	0.836 Scores on a scale Standard Deviation 0.172	—
EQ-5D Health Utility Index Score Cycle 5 Day 1	—	0.838 Scores on a scale Standard Deviation 0.153	—
EQ-5D Health Utility Index Score Cycle 6 Day 1	—	0.825 Scores on a scale Standard Deviation 0.185	—
EQ-5D Health Utility Index Score Cycle 7 Day 1	—	0.818 Scores on a scale Standard Deviation 0.167	—
EQ-5D Health Utility Index Score Cycle 8 Day 1	—	0.831 Scores on a scale Standard Deviation 0.169	—
EQ-5D Health Utility Index Score Cycle 9 Day 1	—	0.845 Scores on a scale Standard Deviation 0.149	—
EQ-5D Health Utility Index Score Cycle 10 Day 1	—	0.840 Scores on a scale Standard Deviation 0.162	—
EQ-5D Health Utility Index Score Cycle 11 Day 1	—	0.820 Scores on a scale Standard Deviation 0.193	—
EQ-5D Health Utility Index Score Cycle 12 Day 1	—	0.810 Scores on a scale Standard Deviation 0.188	—
EQ-5D Health Utility Index Score Cycle 13 Day 1	—	0.839 Scores on a scale Standard Deviation 0.183	—
EQ-5D Health Utility Index Score Cycle 14 Day 1	—	0.842 Scores on a scale Standard Deviation 0.159	—
EQ-5D Health Utility Index Score Cycle 15 Day 1	—	0.840 Scores on a scale Standard Deviation 0.138	—
EQ-5D Health Utility Index Score Cycle 16 Day 1	—	0.830 Scores on a scale Standard Deviation 0.182	—
EQ-5D Health Utility Index Score Cycle 17 Day 1	—	0.837 Scores on a scale Standard Deviation 0.163	—
EQ-5D Health Utility Index Score Cycle 18 Day 1	—	0.836 Scores on a scale Standard Deviation 0.182	—
EQ-5D Health Utility Index Score Cycle 19 Day 1	—	0.848 Scores on a scale Standard Deviation 0.179	—
EQ-5D Health Utility Index Score Cycle 20 Day 1	—	0.853 Scores on a scale Standard Deviation 0.143	—
EQ-5D Health Utility Index Score Cycle 21 Day 1	—	0.868 Scores on a scale Standard Deviation 0.132	—
EQ-5D Health Utility Index Score Cycle 22 Day 1	—	0.864 Scores on a scale Standard Deviation 0.132	—
EQ-5D Health Utility Index Score Cycle 23 Day 1	—	0.846 Scores on a scale Standard Deviation 0.170	—
EQ-5D Health Utility Index Score Cycle 24 Day 1	—	0.864 Scores on a scale Standard Deviation 0.135	—
EQ-5D Health Utility Index Score Cycle 25 Day 1	—	0.861 Scores on a scale Standard Deviation 0.138	—
EQ-5D Health Utility Index Score Cycle 26 Day 1	—	0.869 Scores on a scale Standard Deviation 0.143	—
EQ-5D Health Utility Index Score Cycle 27 Day 1	—	0.884 Scores on a scale Standard Deviation 0.140	—
EQ-5D Health Utility Index Score Cycle 28 Day 1	—	0.876 Scores on a scale Standard Deviation 0.152	—
EQ-5D Health Utility Index Score Cycle 29 Day 1	—	0.852 Scores on a scale Standard Deviation 0.147	—
EQ-5D Health Utility Index Score Cycle 30 Day 1	—	0.857 Scores on a scale Standard Deviation 0.160	—
EQ-5D Health Utility Index Score Cycle 31 Day 1	—	0.784 Scores on a scale Standard Deviation 0.278	—
EQ-5D Health Utility Index Score Cycle 32 Day 1	—	0.864 Scores on a scale Standard Deviation 0.163	—
EQ-5D Health Utility Index Score Cycle 33 Day 1	—	0.870 Scores on a scale Standard Deviation 0.140	—
EQ-5D Health Utility Index Score Cycle 34 Day 1	—	0.838 Scores on a scale Standard Deviation 0.160	—
EQ-5D Health Utility Index Score Cycle 35 Day 1	—	0.905 Scores on a scale Standard Deviation 0.128	—
EQ-5D Health Utility Index Score Cycle 36 Day 1	—	0.779 Scores on a scale Standard Deviation 0.294	—
EQ-5D Health Utility Index Score Cycle 37 Day 1	—	0.854 Scores on a scale Standard Deviation 0.170	—
EQ-5D Health Utility Index Score Cycle 38 Day 1	—	0.810 Scores on a scale Standard Deviation 0.269	—
EQ-5D Health Utility Index Score End of Treatment (EOT)	—	0.698 Scores on a scale Standard Deviation 0.324	—

SECONDARY outcome

Timeframe: The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline.

Population: PRO-evaluable population was only consisted of the Australia cohort

The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The first part was a 5 item questionnaire designed to assess health status in terms of a single index value or utility score. It consisted of 5 descriptors of current health state (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). A respondent was asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/impairment. The answers given to the 5 descriptors permit to find 243 unique health states which can be converted into a single EQ-5D index value by published algorithms. For the EQ-5D index, published weights are available that allow for the creation of a summary score ranging from -0.594 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health.

Outcome measures

Measure	Palbociclib+Letrozole India Cohort Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=146 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+LetrozoleTotal Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Change From Baseline in EQ-5D Health Utility Index Score Baseline (Cycle 1 Day 1)	—	0.786 Scores on a scale Standard Deviation 0.171	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 2 Day 1	—	0.013 Scores on a scale Standard Deviation 0.172	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 3 Day 1	—	0.021 Scores on a scale Standard Deviation 0.156	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 4 Day 1	—	0.052 Scores on a scale Standard Deviation 0.175	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 5 Day 1	—	0.052 Scores on a scale Standard Deviation 0.181	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 6 Day 1	—	0.037 Scores on a scale Standard Deviation 0.214	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 7 Day 1	—	0.033 Scores on a scale Standard Deviation 0.173	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 8 Day 1	—	0.050 Scores on a scale Standard Deviation 0.156	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 9 Day 1	—	0.057 Scores on a scale Standard Deviation 0.165	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 10 Day 1	—	0.049 Scores on a scale Standard Deviation 0.192	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 11 Day 1	—	0.034 Scores on a scale Standard Deviation 0.225	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 12 Day 1	—	0.029 Scores on a scale Standard Deviation 0.235	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 13 Day 1	—	0.058 Scores on a scale Standard Deviation 0.203	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 14 Day 1	—	0.058 Scores on a scale Standard Deviation 0.188	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 15 Day 1	—	0.062 Scores on a scale Standard Deviation 0.184	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 16 Day 1	—	0.051 Scores on a scale Standard Deviation 0.182	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 17 Day 1	—	0.059 Scores on a scale Standard Deviation 0.165	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 18 Day 1	—	0.060 Scores on a scale Standard Deviation 0.181	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 19 Day 1	—	0.061 Scores on a scale Standard Deviation 0.179	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 20 Day 1	—	0.069 Scores on a scale Standard Deviation 0.197	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 21 Day 1	—	0.082 Scores on a scale Standard Deviation 0.169	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 22 Day 1	—	0.076 Scores on a scale Standard Deviation 0.081	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 23 Day 1	—	0.073 Scores on a scale Standard Deviation 0.193	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 24 Day 1	—	0.085 Scores on a scale Standard Deviation 0.183	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 25 Day 1	—	0.083 Scores on a scale Standard Deviation 0.192	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 26 Day 1	—	0.052 Scores on a scale Standard Deviation 0.140	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 27 Day 1	—	0.063 Scores on a scale Standard Deviation 0.129	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 28 Day 1	—	0.071 Scores on a scale Standard Deviation 0.153	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 29 Day 1	—	0.056 Scores on a scale Standard Deviation 0.126	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 30 Day 1	—	0.055 Scores on a scale Standard Deviation 0.122	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 31 Day 1	—	-0.013 Scores on a scale Standard Deviation 0.243	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 32 Day 1	—	0.049 Scores on a scale Standard Deviation 0.099	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 33 Day 1	—	0.060 Scores on a scale Standard Deviation 0.098	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 34 Day 1	—	0.026 Scores on a scale Standard Deviation 0.123	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 35 Day 1	—	0.092 Scores on a scale Standard Deviation 0.134	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 36 Day 1	—	-0.036 Scores on a scale Standard Deviation 0.240	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 37 Day 1	—	0.011 Scores on a scale Standard Deviation 0.107	—
Change From Baseline in EQ-5D Health Utility Index Score Cycle 38 Day 1	—	-0.012 Scores on a scale Standard Deviation 0.232	—
Change From Baseline in EQ-5D Health Utility Index Score End of Treatment (EOT)	—	-0.147 Scores on a scale Standard Deviation 0.239	—
Change From Baseline in EQ-5D Health Utility Index Score End of Study (EOT)	—	-0.022 Scores on a scale Standard Deviation 0.228	—

SECONDARY outcome

Timeframe: The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline.

Population: PRO-evaluable population was only consisted of the Australia cohort

The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The second part consisted of a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state)

Outcome measures

Measure	Palbociclib+Letrozole India Cohort Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=146 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+LetrozoleTotal Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
EQ-VAS Score Cycle 1 Day 1	—	76.9 Scores on a scale Standard Deviation 16.00	—
EQ-VAS Score Cycle 2 Day 1	—	77.3 Scores on a scale Standard Deviation 15.29	—
EQ-VAS Score Cycle 3 Day 1	—	77.4 Scores on a scale Standard Deviation 15.52	—
EQ-VAS Score Cycle 4 Day 1	—	80.3 Scores on a scale Standard Deviation 14.17	—
EQ-VAS Score Cycle 5 Day 1	—	80.4 Scores on a scale Standard Deviation 14.66	—
EQ-VAS Score Cycle 6 Day 1	—	79.8 Scores on a scale Standard Deviation 15.77	—
EQ-VAS Score Cycle 7 Day 1	—	79.7 Scores on a scale Standard Deviation 14.81	—
EQ-VAS Score Cycle 8 Day 1	—	80.1 Scores on a scale Standard Deviation 13.75	—
EQ-VAS Score Cycle 9 Day 1	—	80.9 Scores on a scale Standard Deviation 14.54	—
EQ-VAS Score Cycle 10 Day 1	—	81.2 Scores on a scale Standard Deviation 14.75	—
EQ-VAS Score Cycle 11 Day 1	—	81.0 Scores on a scale Standard Deviation 14.60	—
EQ-VAS Score Cycle 12 Day 1	—	81.3 Scores on a scale Standard Deviation 13.99	—
EQ-VAS Score Cycle 13 Day 1	—	80.4 Scores on a scale Standard Deviation 14.37	—
EQ-VAS Score Cycle 14 Day 1	—	80.9 Scores on a scale Standard Deviation 13.72	—
EQ-VAS Score Cycle 15 Day 1	—	82.1 Scores on a scale Standard Deviation 12.24	—
EQ-VAS Score Cycle 16 Day 1	—	82.9 Scores on a scale Standard Deviation 12.93	—
EQ-VAS Score Cycle 17 Day 1	—	83.1 Scores on a scale Standard Deviation 12.89	—
EQ-VAS Score Cycle 18 Day 1	—	83.1 Scores on a scale Standard Deviation 12.31	—
EQ-VAS Score Cycle 19 Day 1	—	83.7 Scores on a scale Standard Deviation 12.75	—
EQ-VAS Score Cycle 20 Day 1	—	84.5 Scores on a scale Standard Deviation 12.10	—
EQ-VAS Score Cycle 21 Day 1	—	85.3 Scores on a scale Standard Deviation 12.03	—
EQ-VAS Score Cycle 22 Day 1	—	85.5 Scores on a scale Standard Deviation 11.77	—
EQ-VAS Score Cycle 23 Day 1	—	84.1 Scores on a scale Standard Deviation 14.30	—
EQ-VAS Score Cycle 24 Day 1	—	85.6 Scores on a scale Standard Deviation 12.78	—
EQ-VAS Score Cycle 25 Day 1	—	84.9 Scores on a scale Standard Deviation 12.89	—
EQ-VAS Score Cycle 26 Day 1	—	87.6 Scores on a scale Standard Deviation 11.08	—
EQ-VAS Score Cycle 27 Day 1	—	88.1 Scores on a scale Standard Deviation 9.88	—
EQ-VAS Score Cycle 28 Day 1	—	87.5 Scores on a scale Standard Deviation 9.32	—
EQ-VAS Score Cycle 29 Day 1	—	88.5 Scores on a scale Standard Deviation 9.98	—
EQ-VAS Score Cycle 30 Day 1	—	91.5 Scores on a scale Standard Deviation 6.97	—
EQ-VAS Score Cycle 31 Day 1	—	88.1 Scores on a scale Standard Deviation 12.26	—
EQ-VAS Score Cycle 32 Day 1	—	91.0 Scores on a scale Standard Deviation 8.06	—
EQ-VAS Score Cycle 33 Day 1	—	88.6 Scores on a scale Standard Deviation 10.61	—
EQ-VAS Score Cycle 34 Day 1	—	91.0 Scores on a scale Standard Deviation 8.06	—
EQ-VAS Score Cycle 35 Day 1	—	90.0 Scores on a scale Standard Deviation 11	—
EQ-VAS Score Cycle 36 Day 1	—	87.5 Scores on a scale Standard Deviation 14.84	—
EQ-VAS Score Cycle 37 Day 1	—	91.5 Scores on a scale Standard Deviation 7.42	—
EQ-VAS Score Cycle 38 Day 1	—	91.5 Scores on a scale Standard Deviation 0.71	—
EQ-VAS Score End of Treatment (EOT)	—	73.6 Scores on a scale Standard Deviation 23.88	—
EQ-VAS Score End of Study (EOS)	—	77.3 Scores on a scale Standard Deviation 18.99	—

SECONDARY outcome

Timeframe: The descriptive analysis was carried out on Day 1 of each cycle (cycle 1 to cycle 38), at end of treatment (EOT) and end of study (EOS), up to 3 years. Cycle 1 Day 1 is taken to be baseline.

Population: PRO-evaluable population was only consisted of the Australia cohort

The EuroQol-5D (EQ-5D) (version 3L) consisted of 2 parts. The second part consisted of a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state)

Outcome measures

Measure	Palbociclib+Letrozole India Cohort Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=146 Participants Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+LetrozoleTotal Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Change From Baseline in EQ-VAS Score Baseline (Cycle 1 Day 1)	—	76.9 Scores on a scale Standard Deviation 16.00	—
Change From Baseline in EQ-VAS Score Cycle 2 Day 1	—	0.4 Scores on a scale Standard Deviation 13.28	—
Change From Baseline in EQ-VAS Score Cycle 3 Day 1	—	0.3 Scores on a scale Standard Deviation 13.47	—
Change From Baseline in EQ-VAS Score Cycle 4 Day 1	—	2.9 Scores on a scale Standard Deviation 13.06	—
Change From Baseline in EQ-VAS Score Cycle 5 Day 1	—	3.2 Scores on a scale Standard Deviation 14.70	—
Change From Baseline in EQ-VAS Score Cycle 6 Day 1	—	2.3 Scores on a scale Standard Deviation 15.53	—
Change From Baseline in EQ-VAS Score Cycle 7 Day 1	—	2.0 Scores on a scale Standard Deviation 15.79	—
Change From Baseline in EQ-VAS Score Cycle 8 Day 1	—	2.4 Scores on a scale Standard Deviation 13.64	—
Change From Baseline in EQ-VAS Score Cycle 9 Day 1	—	2.3 Scores on a scale Standard Deviation 12.54	—
Change From Baseline in EQ-VAS Score Cycle 10 Day 1	—	2.4 Scores on a scale Standard Deviation 14.44	—
Change From Baseline in EQ-VAS Score Cycle 11 Day 1	—	2.1 Scores on a scale Standard Deviation 13.72	—
Change From Baseline in EQ-VAS Score Cycle 12 Day 1	—	2.9 Scores on a scale Standard Deviation 13.76	—
Change From Baseline in EQ-VAS Score Cycle 13 Day 1	—	2.1 Scores on a scale Standard Deviation 13.84	—
Change From Baseline in EQ-VAS Score Cycle 14 Day 1	—	2.3 Scores on a scale Standard Deviation 14.00	—
Change From Baseline in EQ-VAS Score Cycle 15 Day 1	—	3.5 Scores on a scale Standard Deviation 12.12	—
Change From Baseline in EQ-VAS Score Cycle 16 Day 1	—	3.7 Scores on a scale Standard Deviation 13.82	—
Change From Baseline in EQ-VAS Score Cycle 17 Day 1	—	3.9 Scores on a scale Standard Deviation 12.77	—
Change From Baseline in EQ-VAS Score Cycle 18 Day 1	—	4.5 Scores on a scale Standard Deviation 11.86	—
Change From Baseline in EQ-VAS Score Cycle 19 Day 1	—	4.6 Scores on a scale Standard Deviation 11.69	—
Change From Baseline in EQ-VAS Score Cycle 20 Day 1	—	5.5 Scores on a scale Standard Deviation 12.58	—
Change From Baseline in EQ-VAS Score Cycle 21 Day 1	—	6.0 Scores on a scale Standard Deviation 11.77	—
Change From Baseline in EQ-VAS Score Cycle 22 Day 1	—	5.0 Scores on a scale Standard Deviation 9.71	—
Change From Baseline in EQ-VAS Score Cycle 23 Day 1	—	4.4 Scores on a scale Standard Deviation 13.20	—
Change From Baseline in EQ-VAS Score Cycle 24 Day 1	—	4.6 Scores on a scale Standard Deviation 11.93	—
Change From Baseline in EQ-VAS Score Cycle 25 Day 1	—	4.3 Scores on a scale Standard Deviation 10.71	—
Change From Baseline in EQ-VAS Score Cycle 26 Day 1	—	4.4 Scores on a scale Standard Deviation 8.63	—
Change From Baseline in EQ-VAS Score Cycle 27 Day 1	—	5.6 Scores on a scale Standard Deviation 6.26	—
Change From Baseline in EQ-VAS Score Cycle 28 Day 1	—	5.5 Scores on a scale Standard Deviation 8.24	—
Change From Baseline in EQ-VAS Score Cycle 29 Day 1	—	5.9 Scores on a scale Standard Deviation 7.57	—
Change From Baseline in EQ-VAS Score Cycle 30 Day 1	—	6.5 Scores on a scale Standard Deviation 7.88	—
Change From Baseline in EQ-VAS Score Cycle 31 Day 1	—	4.3 Scores on a scale Standard Deviation 11.52	—
Change From Baseline in EQ-VAS Score Cycle 32 Day 1	—	7.3 Scores on a scale Standard Deviation 10.59	—
Change From Baseline in EQ-VAS Score Cycle 33 Day 1	—	7.1 Scores on a scale Standard Deviation 12.75	—
Change From Baseline in EQ-VAS Score Cycle 34 Day 1	—	7.6 Scores on a scale Standard Deviation 6.68	—
Change From Baseline in EQ-VAS Score Cycle 35 Day 1	—	6.6 Scores on a scale Standard Deviation 9.27	—
Change From Baseline in EQ-VAS Score Cycle 36 Day 1	—	3.5 Scores on a scale Standard Deviation 8.22	—
Change From Baseline in EQ-VAS Score Cycle 37 Day 1	—	10.3 Scores on a scale Standard Deviation 1.71	—
Change From Baseline in EQ-VAS Score Cycle 38 Day 1	—	9.0 Scores on a scale Standard Deviation 4.24	—
Change From Baseline in EQ-VAS Score End of Treatment (EOT)	—	-3.2 Scores on a scale Standard Deviation 22.24	—
Change From Baseline in EQ-VAS Score End of Study (EOS)	—	0.4 Scores on a scale Standard Deviation 19.72	—

Adverse Events

Palbociclib+Letrozole India Cohort

Serious events: 18 serious events

Other events: 85 other events

Deaths: 3 deaths

Palbociclib+Letrozole Australia Cohort

Serious events: 45 serious events

Other events: 151 other events

Deaths: 7 deaths

Serious adverse events

Measure	Palbociclib+Letrozole India Cohort n=100 participants at risk Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=152 participants at risk Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Blood and lymphatic system disorders Anaemia	4.0% 4/100 • Number of events 4 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Febrile neutropenia	3.0% 3/100 • Number of events 3 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	2.0% 3/152 • Number of events 3 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Neutropenia	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Thrombocytopenia	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Acute coronary syndrome	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Stress cardiomyopathy	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	1.3% 2/152 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	1.3% 2/152 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Ascites	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Diarrhoea	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Gastritis	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Odynophagia	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Vomiting	3.0% 3/100 • Number of events 3 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Disease progression	2.0% 2/100 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.9% 6/152 • Number of events 6 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Malaise	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Multiple organ dysfunction syndrome	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Pain	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	1.3% 2/152 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Pyrexia	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Immune system disorders Anaphylactic reaction	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Appendicitis	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	1.3% 2/152 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Aspergillus infection	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Cellulitis	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	1.3% 2/152 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Enterocolitis bacterial	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Gastroenteritis	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Herpes zoster	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Influenza	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Lower respiratory tract infection	2.0% 2/100 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Pneumonia	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Pyelonephritis	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Upper respiratory infection	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	1.3% 2/152 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Urinary tract infection	1.0% 1/100 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	2.0% 3/152 • Number of events 3 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Wound infection	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Fall	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Subdural haematoma	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Liver function test increased	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Dehydration	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	1.3% 2/152 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypoglycaemia	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Pathological fracture	3.0% 3/100 • Number of events 3 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Cerebral infarction	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Headache	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 3 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Sciatica	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Transient global amnesia	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Transient ischaemic attack	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Anxiety	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Renal and urinary disorders Hydronephrosis	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.3% 5/152 • Number of events 6 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Vascular disorders Venous stenosis	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.66% 1/152 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Other adverse events

Measure	Palbociclib+Letrozole India Cohort n=100 participants at risk Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information	Palbociclib+Letrozole Australia Cohort n=152 participants at risk Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information
Blood and lymphatic system disorders Anaemia	22.0% 22/100 • Number of events 58 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.6% 10/152 • Number of events 14 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Neutropenia	57.0% 57/100 • Number of events 218 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	72.4% 110/152 • Number of events 656 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Thrombocytopenia	10.0% 10/100 • Number of events 34 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.9% 15/152 • Number of events 38 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Eye disorders Vision blurred	2.0% 2/100 • Number of events 7 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.3% 8/152 • Number of events 8 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain	3.0% 3/100 • Number of events 3 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.6% 10/152 • Number of events 12 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain upper	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 9/152 • Number of events 11 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Constipation	7.0% 7/100 • Number of events 8 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	21.1% 32/152 • Number of events 45 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Diarrhoea	7.0% 7/100 • Number of events 7 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	33.6% 51/152 • Number of events 76 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	8.6% 13/152 • Number of events 13 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Mouth ulceration	3.0% 3/100 • Number of events 3 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	22.4% 34/152 • Number of events 50 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Nausea	3.0% 3/100 • Number of events 3 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	37.5% 57/152 • Number of events 80 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Vomiting	8.0% 8/100 • Number of events 8 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	22.4% 34/152 • Number of events 47 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Asthenia	8.0% 8/100 • Number of events 9 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/152 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Chest pain	2.0% 2/100 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	8.6% 13/152 • Number of events 19 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Fatigue	9.0% 9/100 • Number of events 24 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	65.1% 99/152 • Number of events 132 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Influenza like illness	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.2% 14/152 • Number of events 17 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Mucosal inflammation	2.0% 2/100 • Number of events 4 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	21.7% 33/152 • Number of events 61 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Oedema peripheral	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 9/152 • Number of events 10 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Pain	6.0% 6/100 • Number of events 6 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.9% 6/152 • Number of events 6 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Pyrexia	14.0% 14/100 • Number of events 16 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	3.3% 5/152 • Number of events 5 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Gastroenteritis	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	7.2% 11/152 • Number of events 12 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Lower respiratory tract infection	2.0% 2/100 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 9/152 • Number of events 11 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Nasopharyngitis	3.0% 3/100 • Number of events 6 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	7.9% 12/152 • Number of events 13 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Oral herpes	1.0% 1/100 • Number of events 3 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	7.9% 12/152 • Number of events 15 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Upper respiratory tract infection	5.0% 5/100 • Number of events 5 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	37.5% 57/152 • Number of events 87 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Urinary tract infection	4.0% 4/100 • Number of events 7 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.2% 14/152 • Number of events 17 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Contusion	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.3% 8/152 • Number of events 8 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Fall	2.0% 2/100 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.6% 10/152 • Number of events 11 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations White blood cell count decreased	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.9% 15/152 • Number of events 23 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Decreased appetite	4.0% 4/100 • Number of events 4 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.5% 19/152 • Number of events 24 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Arthralgia	6.0% 6/100 • Number of events 6 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	34.2% 52/152 • Number of events 82 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Back pain	9.0% 9/100 • Number of events 10 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	23.0% 35/152 • Number of events 49 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	10.5% 16/152 • Number of events 19 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.5% 19/152 • Number of events 25 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.0% 2/100 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.6% 10/152 • Number of events 12 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Myalgia	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	15.1% 23/152 • Number of events 32 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Neck pain	2.0% 2/100 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	7.9% 12/152 • Number of events 14 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	7.0% 7/100 • Number of events 8 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.4% 25/152 • Number of events 26 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.3% 8/152 • Number of events 8 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Dizziness	3.0% 3/100 • Number of events 3 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	12.5% 19/152 • Number of events 21 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Headache	4.0% 4/100 • Number of events 5 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	30.9% 47/152 • Number of events 71 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Hypoaesthesia	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 9/152 • Number of events 9 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Paraesthesia	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	7.2% 11/152 • Number of events 12 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Anxiety	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.3% 8/152 • Number of events 10 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Depression	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.3% 8/152 • Number of events 8 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Psychiatric disorders Insomina	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	11.8% 18/152 • Number of events 20 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 10/100 • Number of events 15 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	15.1% 23/152 • Number of events 28 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.0% 6/100 • Number of events 8 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	13.2% 20/152 • Number of events 28 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	10.5% 16/152 • Number of events 20 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 2/100 • Number of events 2 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	9.2% 14/152 • Number of events 21 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.0% 1/100 • Number of events 1 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.3% 8/152 • Number of events 8 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Alopecia	17.0% 17/100 • Number of events 18 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	21.7% 33/152 • Number of events 35 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.6% 10/152 • Number of events 12 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	5.9% 9/152 • Number of events 9 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Pruritus	4.0% 4/100 • Number of events 6 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	11.2% 17/152 • Number of events 26 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Rash	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	13.8% 21/152 • Number of events 40 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Vascular disorders Hot flush	0.00% 0/100 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	23.0% 35/152 • Number of events 36 • AEs (serious and non-serious) were recorded on the CRF from the time the participant had taken at least 1 dose of investigational product through and including 28 calendar days after the last administration of the study treatment, an average of 14 months The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Additional Information

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Results disclosure agreements

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

Restriction type: OTHER