Trial Outcomes & Findings for A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer. (NCT NCT01783444)

NCT ID: NCT01783444

Last Updated: 2021-02-26

Results Overview

Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 309 participants
• Primary outcome timeframe: Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months
• Results posted on: 2021-02-26

Participant Flow

This study was conducted at 84 centers in 18 countries worldwide: Belgium (1), Denmark (6), Hungary (3), Ireland (3), Spain (4), Sweden (6), United Kingdom (3), United States (19), Argentina (6), Brazil (5), Peru (4), India (4), Lebanon (5), Malaysia (2), Russia (3), Thailand (3), Turkey (3) Australia (4)

A total of 300 subjects were planned and total of 309 subjects were randomized to everolimus plus exemestane (control arm) (N = 104), everolimus alone (N = 103), or capecitabine (N = 102).

Participant milestones

Measure	Everolimus 10 mg + Exemestane 25 mg Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Treatment Phase STARTED	104	103	102
Treatment Phase Safety Set	104	103	102
Treatment Phase COMPLETED	0	0	0
Treatment Phase NOT COMPLETED	104	103	102
Post-Treatment Efficacy Follow-Up Phase STARTED	96	93	91
Post-Treatment Efficacy Follow-Up Phase COMPLETED	0	0	0
Post-Treatment Efficacy Follow-Up Phase NOT COMPLETED	96	93	91

Reasons for withdrawal

Measure	Everolimus 10 mg + Exemestane 25 mg Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Treatment Phase Adverse Event	9	20	19
Treatment Phase Disease Progression	76	66	64
Treatment Phase Death	2	2	2
Treatment Phase Protocol Violation	1	1	2
Treatment Phase Withdrawal by Subject	6	8	9
Treatment Phase Administrative problems	2	0	1
Treatment Phase Physician Decision	8	6	5
Post-Treatment Efficacy Follow-Up Phase Disease Progression	7	8	11
Post-Treatment Efficacy Follow-Up Phase Death	9	7	5
Post-Treatment Efficacy Follow-Up Phase Withdrawal by Subject	4	8	8
Post-Treatment Efficacy Follow-Up Phase Administrative Problems	0	1	0
Post-Treatment Efficacy Follow-Up Phase New cancer therapy	7	16	15
Post-Treatment Efficacy Follow-Up Phase Followup phase completed as per protocol	69	53	52

Baseline Characteristics

A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.

Baseline characteristics by cohort

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 Participants Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=103 Participants Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 n=102 Participants Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).	Total n=309 Participants Total of all reporting groups
Age, Continuous	60.9 Years STANDARD_DEVIATION 10.47 • n=5 Participants	61.3 Years STANDARD_DEVIATION 9.08 • n=7 Participants	59.7 Years STANDARD_DEVIATION 10.50 • n=5 Participants	60.6 Years STANDARD_DEVIATION 10.03 • n=4 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	103 Participants n=7 Participants	102 Participants n=5 Participants	309 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	78 Participants n=5 Participants	85 Participants n=7 Participants	91 Participants n=5 Participants	254 Participants n=4 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Asian	11 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	27 Participants n=4 Participants
Race/Ethnicity, Customized Native American	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Other	11 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	20 Participants n=4 Participants
ECOG Performance Status No Restrictions	54 Participants n=5 Participants	48 Participants n=7 Participants	57 Participants n=5 Participants	159 Participants n=4 Participants
ECOG Performance Status Only Light Work	42 Participants n=5 Participants	50 Participants n=7 Participants	39 Participants n=5 Participants	131 Participants n=4 Participants
ECOG Performance Status Only Self Care	5 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
ECOG Performance Status Missing	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months

Population: Full Analysis Set (FAS), which consisted of all randomized patients, was considered.

Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy.

Outcome measures

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 Participants Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=103 Participants Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Everolimus Alone	8.41 Months Interval 6.6 to 9.72	6.77 Months Interval 5.52 to 7.2	—

SECONDARY outcome

Timeframe: Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to 39 months

Population: Full Analysis Set (FAS), which consisted of all randomized patients, was considered.

Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. PFS was compared between the everolimus + exemestane combination therapy with the everolimus monotherapy.

Outcome measures

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 Participants Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=102 Participants Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Progression Free Survival (PFS) - Everolimus Plus Exemestane Versus Capecitabine Alone	8.41 Months Interval 6.6 to 9.72	9.59 Months Interval 8.25 to 15.05	—

SECONDARY outcome

Timeframe: Every 3 months following end of treatment visit, assessed for approximately 54 months

Population: Full Analysis Set (FAS), which consisted of all randomized patients, was considered.

Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive.

Outcome measures

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 Participants Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=103 Participants Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 n=102 Participants Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Overall Survival (OS)	23.06 Months Interval 19.48 to 27.96	29.27 Months Interval 24.28 to 31.77	25.56 Months Interval 23.82 to 33.35

SECONDARY outcome

Timeframe: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months

Population: Full Analysis Set (FAS), which consisted of all randomized patients, was considered.

Overall Response Rate (ORR) as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST 1.1 This was assessed in the full patient population. Complete response is achieved when all lesions evaluated at baseline are absent at subsequent visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Only descriptive statistics.

Outcome measures

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 Participants Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=103 Participants Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 n=102 Participants Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Overall Response Rate (ORR)	21 Percentage of Participants Interval 13.9 to 27.8	12 Percentage of Participants Interval 6.9 to 18.2	23 Percentage of Participants Interval 15.9 to 30.4

SECONDARY outcome

Timeframe: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 43 months

Population: Full Analysis Set (FAS), which consisted of all randomized patients, was considered.

Clinical Benefit Rate (CBR) is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 24 weeks based on local investigator's assessment according to RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, Stable disease (SD), neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; CBR = CR+PR+SD. Only descriptive statistics.

Outcome measures

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 Participants Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=103 Participants Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 n=102 Participants Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Clinical Benefit Rate (CBR)	59 Percentage of Participants Interval 48.2 to 65.0	43 Percentage of Participants Interval 33.5 to 50.3	53 Percentage of Participants Interval 43.4 to 60.5

SECONDARY outcome

Timeframe: Baseline, every 6 weeks up to about 43 months

Population: Full Analysis Set (FAS), which consisted of all randomized patients, was considered.

The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess physical health of subjects,ranging from 0 (most active) to 5 (least active). Definitive deterioration is defined as no improvement in the ECOG status following observation of the deterioration.

Outcome measures

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 Participants Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=103 Participants Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 n=102 Participants Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Time to Eastern Cooperative Oncology Group (ECOG) Performance Deterioration	72.57 Weeks Interval 38.71 to NA: Not estimable due to high number of censors primarily due to treatment discontinuation.	126.57 Weeks Interval 72.14 to NA: Not estimable due to high number of censors primarily due to treatment discontinuation	120.00 Weeks Interval 72.57 to NA: Not estimable due to high number of censors primarily due to treatment discontinuation

SECONDARY outcome

Timeframe: Baseline, every 6 weeks up to about 43 months

Population: Full Analysis Set (FAS), which consisted of all randomized patients, was considered.

The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive 10% (5-point) deterioration is defined as a decrease in score by at least 10% (5-points) compared to baseline, with no later increase above this threshold observed during the course of the study.

Outcome measures

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 Participants Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=103 Participants Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 n=102 Participants Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Time to 10% Definitive Deterioration in the Global Health Status / Quality of Life	30.86 Weeks Interval 24.29 to 78.0	23.86 Weeks Interval 12.57 to 24.71	61.29 Weeks Interval 36.86 to 143.71

SECONDARY outcome

Timeframe: Week 3, Week 12

Population: Full Analysis Set (FAS), which consisted of all randomized patients, was considered. Only participants who had both post-baseline assessments were included.

TSQM was used to measure the Patients' self-reported satisfaction or dissatisfaction with the study treatment. The differences in mean scale scores between weeks 3 and 12 comparing treatment satisfaction in the different treatment arms: everolimus + exemestane combination therapy versus everolimus monotherapy, and everolimus + exemestane combination therapy versus capecitabine monotherapy. The TSQM version 1.4 domain scores range from 0 to 100 with higher scores representing a higher satisfaction on that domain.

Outcome measures

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 Participants Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=103 Participants Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 n=102 Participants Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Between Week 3 and 12 Effectiveness	-2.2 Unit on a scale Standard Deviation 20.15	1.2 Unit on a scale Standard Deviation 26.51	1.2 Unit on a scale Standard Deviation 21.61
Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Between Week 3 and 12 Convenience	-0.6 Unit on a scale Standard Deviation 12.00	1.0 Unit on a scale Standard Deviation 16.41	0.5 Unit on a scale Standard Deviation 17.67
Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Between Week 3 and 12 Global satisfaction	-1.0 Unit on a scale Standard Deviation 17.32	1.8 Unit on a scale Standard Deviation 20.80	2.3 Unit on a scale Standard Deviation 16.96
Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Between Week 3 and 12 Side-effects	-4.8 Unit on a scale Standard Deviation 28.88	-9.1 Unit on a scale Standard Deviation 21.88	-2.6 Unit on a scale Standard Deviation 22.45

POST_HOC outcome

Timeframe: up to 224 weeks (on-treatment), up to approximately 5 years (study duration)

Population: Clinical database population; all treated patients

On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks).

Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 5 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.

Outcome measures

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 Participants Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=103 Participants Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 n=102 Participants Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
All Collected Deaths On-treatment deaths	9 Participants	5 Participants	2 Participants
All Collected Deaths Post-treatment deaths	62 Participants	55 Participants	57 Participants
All Collected Deaths All deaths	71 Participants	60 Participants	59 Participants

Adverse Events

Everolimus 10 mg + Exemestane 25 mg

Serious events: 37 serious events

Other events: 103 other events

Deaths: 9 deaths

Everolimus 10 mg

Serious events: 30 serious events

Other events: 100 other events

Deaths: 5 deaths

Capecitabine 1250 mg/m2

Serious events: 30 serious events

Other events: 99 other events

Deaths: 2 deaths

Serious adverse events

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 participants at risk Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=103 participants at risk Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 n=102 participants at risk Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Blood and lymphatic system disorders Anaemia	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Blood and lymphatic system disorders Leukopenia	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Blood and lymphatic system disorders Neutropenia	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Blood and lymphatic system disorders Pancytopenia	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Cardiac disorders Atrial fibrillation	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Cardiac disorders Cardiac arrest	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Cardiac disorders Cardiac failure	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Cardiac disorders Cardiac failure acute	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Cardiac disorders Cardiac failure congestive	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Cardiac disorders Cardio-respiratory arrest	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Cardiac disorders Pericardial effusion	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Ear and labyrinth disorders Vertigo positional	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Eye disorders Diplopia	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Abdominal pain	1.9% 2/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.0% 2/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Ascites	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Colitis	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Constipation	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Diarrhoea	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	1.9% 2/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Dysphagia	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Ileus	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Large intestinal obstruction	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Nausea	2.9% 3/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Rectal haemorrhage	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Stomatitis	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	1.9% 2/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Vomiting	1.9% 2/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Death	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Drug intolerance	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Fatigue	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.0% 2/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders General physical health deterioration	3.8% 4/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Hernia	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Multiple organ dysfunction syndrome	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Non-cardiac chest pain	1.9% 2/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Oedema peripheral	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Performance status decreased	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Hepatobiliary disorders Bile duct obstruction	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Hepatobiliary disorders Hepatic failure	1.9% 2/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Bacterial pyelonephritis	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Ear infection	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Erysipelas	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Escherichia sepsis	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Gastroenteritis	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Infected cyst	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Infection	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Lung infection	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Pneumocystis jirovecii pneumonia	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Pneumonia	7.7% 8/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.0% 2/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Pyelonephritis	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Sepsis	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Septic shock	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Urinary tract infection	2.9% 3/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Urosepsis	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Injury, poisoning and procedural complications Ilium fracture	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Alanine aminotransferase increased	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Aspartate aminotransferase increased	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Blood triglycerides increased	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Blood uric acid increased	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Body temperature increased	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Ejection fraction decreased	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Gamma-glutamyltransferase increased	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Platelet count decreased	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Dehydration	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Failure to thrive	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Hyperkalaemia	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Hypocalcaemia	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.0% 2/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Back pain	1.9% 2/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Mobility decreased	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Pain in extremity	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	1.9% 2/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Nervous system disorders Cerebrovascular accident	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Nervous system disorders Headache	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Nervous system disorders Hypoaesthesia	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Nervous system disorders Seizure	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Nervous system disorders Syncope	1.9% 2/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Nervous system disorders Transient ischaemic attack	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Renal and urinary disorders Acute kidney injury	2.9% 3/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.0% 2/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Renal and urinary disorders Nephrolithiasis	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.9% 2/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 2/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	1.9% 2/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.0% 2/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.9% 2/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.9% 2/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.0% 2/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Skin and subcutaneous tissue disorders Skin toxicity	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Vascular disorders Deep vein thrombosis	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Vascular disorders Hypotension	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Vascular disorders Hypovolaemic shock	0.00% 0/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).

Other adverse events

Measure	Everolimus 10 mg + Exemestane 25 mg n=104 participants at risk Everolimus (10 mg daily) with Exemestane (25 mg daily) (control arm).	Everolimus 10 mg n=103 participants at risk Everolimus (10 mg daily) (investigational arm).	Capecitabine 1250 mg/m2 n=102 participants at risk Capecitabine (1250 mg/m2 twice daily) for two weeks, followed by one week rest period in 3-weeks cycles (investigational arm).
Blood and lymphatic system disorders Anaemia	30.8% 32/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	25.2% 26/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	21.6% 22/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Blood and lymphatic system disorders Neutropenia	3.8% 4/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	13.7% 14/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Blood and lymphatic system disorders Thrombocytopenia	3.8% 4/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	6.8% 7/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Eye disorders Dry eye	1.9% 2/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	6.9% 7/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Eye disorders Lacrimation increased	2.9% 3/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	8.8% 9/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Abdominal pain	9.6% 10/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	8.7% 9/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	12.7% 13/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Abdominal pain upper	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.9% 6/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Constipation	13.5% 14/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	14.6% 15/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	17.6% 18/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Diarrhoea	34.6% 36/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	33.0% 34/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	53.9% 55/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Dry mouth	9.6% 10/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	10.7% 11/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	11.8% 12/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Dyspepsia	7.7% 8/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	6.9% 7/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Mouth ulceration	14.4% 15/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	12.6% 13/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Nausea	33.7% 35/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	20.4% 21/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	51.0% 52/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Stomatitis	49.0% 51/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	43.7% 45/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	23.5% 24/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Toothache	4.8% 5/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.8% 6/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Gastrointestinal disorders Vomiting	19.2% 20/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	13.6% 14/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	28.4% 29/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Asthenia	24.0% 25/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	8.7% 9/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	23.5% 24/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Fatigue	37.5% 39/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	31.1% 32/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	33.3% 34/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Non-cardiac chest pain	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Oedema peripheral	28.8% 30/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	21.4% 22/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	15.7% 16/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
General disorders Pyrexia	17.3% 18/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	11.7% 12/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	8.8% 9/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Pneumonia	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	6.8% 7/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.0% 2/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Rash pustular	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Upper respiratory tract infection	7.7% 8/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	7.8% 8/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Infections and infestations Urinary tract infection	11.5% 12/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	7.8% 8/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Alanine aminotransferase increased	15.4% 16/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	9.7% 10/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.9% 6/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Aspartate aminotransferase increased	15.4% 16/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	13.6% 14/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	8.8% 9/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Blood cholesterol increased	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	8.7% 9/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Blood creatinine increased	7.7% 8/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.8% 6/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Gamma-glutamyltransferase increased	14.4% 15/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	15.5% 16/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.0% 2/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Platelet count decreased	7.7% 8/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Investigations Weight decreased	29.8% 31/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	24.3% 25/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	14.7% 15/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Decreased appetite	33.7% 35/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	31.1% 32/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	26.5% 27/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Dehydration	8.7% 9/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Hypercholesterolaemia	2.9% 3/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	8.7% 9/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Hyperglycaemia	12.5% 13/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	17.5% 18/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	7.8% 8/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Hypertriglyceridaemia	4.8% 5/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	14.6% 15/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	8.8% 9/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Metabolism and nutrition disorders Hypokalaemia	10.6% 11/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.8% 6/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Arthralgia	10.6% 11/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	15.5% 16/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	12.7% 13/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Back pain	19.2% 20/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	7.8% 8/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	11.8% 12/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Bone pain	8.7% 9/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	6.9% 7/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Muscle spasms	2.9% 3/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.8% 6/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	9.6% 10/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	6.8% 7/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	7.8% 8/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	10.6% 11/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	8.8% 9/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Myalgia	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Neck pain	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Musculoskeletal and connective tissue disorders Pain in extremity	13.5% 14/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	12.6% 13/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	15.7% 16/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Nervous system disorders Dizziness	7.7% 8/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	8.7% 9/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.9% 6/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Nervous system disorders Dysgeusia	16.3% 17/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	19.4% 20/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	13.7% 14/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Nervous system disorders Headache	16.3% 17/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	15.5% 16/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	12.7% 13/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Nervous system disorders Neuropathy peripheral	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	6.9% 7/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Nervous system disorders Paraesthesia	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	1.9% 2/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Psychiatric disorders Anxiety	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	1.9% 2/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Psychiatric disorders Depression	7.7% 8/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Psychiatric disorders Insomnia	9.6% 10/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	7.8% 8/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	10.8% 11/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Renal and urinary disorders Dysuria	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Reproductive system and breast disorders Breast pain	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.97% 1/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.9% 6/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Cough	35.6% 37/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	15.5% 16/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	17.6% 18/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.3% 18/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	18.4% 19/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	16.7% 17/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 13/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	10.7% 11/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.8% 4/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	6.8% 7/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.98% 1/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.8% 4/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.9% 6/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Respiratory, thoracic and mediastinal disorders Pneumonitis	21.2% 22/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	20.4% 21/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Skin and subcutaneous tissue disorders Alopecia	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.9% 6/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Skin and subcutaneous tissue disorders Dermatitis acneiform	6.7% 7/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Skin and subcutaneous tissue disorders Dry skin	10.6% 11/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.8% 6/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	13.7% 14/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Skin and subcutaneous tissue disorders Erythema	5.8% 6/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	3.9% 4/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	2.9% 3/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	2.9% 3/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	60.8% 62/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Skin and subcutaneous tissue disorders Pruritus	10.6% 11/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	7.8% 8/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	6.9% 7/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Skin and subcutaneous tissue disorders Rash	21.2% 22/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	22.3% 23/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	11.8% 12/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.96% 1/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	0.00% 0/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	5.9% 6/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).
Vascular disorders Hypertension	14.4% 15/104 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	7.8% 8/103 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).	4.9% 5/102 • Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 224 weeks (treatment duration ranged from 1.3 to 220.0 weeks). Any sign or symptom that occurs during the study treatment and 30 days post treatment follow up. Maximum exposure to study treatments = 201 weeks (Everolimus + Exemestane treatment group), 145 weeks (Everolimus treatment group) and 220 weeks (Capecitabine treatment group).

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER