Trial Outcomes & Findings for Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole (NCT NCT00863655)

NCT ID: NCT00863655

Last Updated: 2017-05-02

Results Overview

Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of ≥1 new lytic lesions in bone; the appearance of ≥ new lesions outside of bone and unequivocal progression of existing bone lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 724 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 about 19 months
• Results posted on: 2017-05-02

Participant Flow

Although 724 patients were randomized, 4 never received any study treatment and thus were excluded form the safety set.

Participant milestones

Measure	Everolimus + Exemestane Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane Placebo of everolimus in combination with exemestane 25 mg daily
Overall Study STARTED	485	239
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	485	239

Reasons for withdrawal

Measure	Everolimus + Exemestane Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane Placebo of everolimus in combination with exemestane 25 mg daily
Overall Study Protocol Violation	4	0
Overall Study Adverse Event	52	8
Overall Study Withdrawal by Subject	47	7
Overall Study Administrative problems	1	0
Overall Study Death	7	1
Overall Study New cancer therapy	5	1
Overall Study Disease progression	364	221
Overall Study Treatment completed as per protocol	5	1

Baseline Characteristics

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

Baseline characteristics by cohort

Measure	Everolimus + Exemestane n=485 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=239 Participants Placebo of everolimus in combination with exemestane 25 mg daily	Total n=724 Participants Total of all reporting groups
Age, Continuous	62.5 years STANDARD_DEVIATION 10.31 • n=5 Participants	61.2 years STANDARD_DEVIATION 9.75 • n=7 Participants	62.1 years STANDARD_DEVIATION 10.14 • n=5 Participants
Age, Customized < 65 years	290 Participants n=5 Participants	159 Participants n=7 Participants	449 Participants n=5 Participants
Age, Customized >= 65 years	195 Participants n=5 Participants	80 Participants n=7 Participants	275 Participants n=5 Participants
Sex: Female, Male Female	485 Participants n=5 Participants	239 Participants n=7 Participants	724 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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 about 19 months

Population: All randomized patients were included in the Full Analysis Set.

Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of ≥1 new lytic lesions in bone; the appearance of ≥ new lesions outside of bone and unequivocal progression of existing bone lesions.

Outcome measures

Measure	Everolimus + Exemestane n=485 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=239 Participants Placebo of everolimus in combination with exemestane 25 mg daily
Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.	6.93 months Interval 6.44 to 8.05	2.83 months Interval 2.76 to 4.14

SECONDARY outcome

Timeframe: up to 53 months

Population: All randomized patients were included in the Full Analysis Set.

Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact.

Outcome measures

Measure	Everolimus + Exemestane n=485 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=239 Participants Placebo of everolimus in combination with exemestane 25 mg daily
Overall Survival (OS) by Number of Deaths	267 Participants	143 Participants

SECONDARY outcome

Timeframe: up to 53 months

Population: All randomized patients were included in the Full Analysis Set.

Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause.

Outcome measures

Measure	Everolimus + Exemestane n=485 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=239 Participants Placebo of everolimus in combination with exemestane 25 mg daily
Overall Survival (OS) by Median	30.98 Months Interval 27.96 to 34.56	26.55 Months Interval 22.57 to 33.08

SECONDARY outcome

Timeframe: up to 21 months

Population: All randomized patients were included in the Full Analysis Set.

Overall response rate (ORR) is the percentage of patients with a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.

Outcome measures

Measure	Everolimus + Exemestane n=485 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=239 Participants Placebo of everolimus in combination with exemestane 25 mg daily
Overall Response Rate (ORR)	9.5 Percentage of participants	0.4 Percentage of participants

SECONDARY outcome

Timeframe: up to 21 months

Population: All randomized patients were included in the Full Analysis Set.

CBR is defined as the percentage of patients with best overall response of either complete response (CR), a partial response (PR) or stable disease (SD) >= 24 weeks, according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.

Outcome measures

Measure	Everolimus + Exemestane n=485 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=239 Participants Placebo of everolimus in combination with exemestane 25 mg daily
Clinical Benefit Rate (CBR)	33.4 Percentage of participants	18.0 Percentage of participants

SECONDARY outcome

Timeframe: 2, 4, 6, 9 months

Population: All randomized patients were included in the Full Analysis Set.

The ECOG PS (Eastern Cooperative Oncology Group Performance Scale) is a standard criteria for measuring how treatment of cancer impacts level of functioning in terms of the ability to care for oneself, daily activity, & physical ability (walking, working, etc.). Scale score ranges:0 to 5, 5 being the worst. Scale index: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature. 2: Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours. 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead. A deterioration of ECOG is an increase of 1 of the ECOG PS without improvement back to initial level at a subsequent time of measurement.

Outcome measures

Measure	Everolimus + Exemestane n=485 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=239 Participants Placebo of everolimus in combination with exemestane 25 mg daily
Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier 2 Months	0.84 Proportion of patients Interval 0.8 to 0.87	0.87 Proportion of patients Interval 0.82 to 0.91
Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier 4 Months	0.74 Proportion of patients Interval 0.7 to 0.78	0.80 Proportion of patients Interval 0.73 to 0.85
Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier 6 Months	0.64 Proportion of patients Interval 0.58 to 0.69	0.67 Proportion of patients Interval 0.57 to 0.75
Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier 9 Months	0.57 Proportion of patients Interval 0.5 to 0.63	0.47 Proportion of patients Interval 0.32 to 0.61

SECONDARY outcome

Timeframe: Up to 21 months

Population: All randomized patients were included in the Full Analysis Set.

The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status - QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. All of the scales measures range in score from 0 to 100. A high scale score = higher response level. Thus a high score for a functional scale represents a healthy level of function, a high score for the global health status / QoL represents a high quality of life but a high score for a symptom scale / item represents a high level of symptomatology / problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

Outcome measures

Measure	Everolimus + Exemestane n=485 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=239 Participants Placebo of everolimus in combination with exemestane 25 mg daily
Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30 Deterioration global health status score ≥ 5%	4.53 Months Interval 4.17 to 5.68	4.40 Months Interval 3.58 to 5.85
Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30 Deterioration in PF domain score of ≥ 5%	4.83 Months Interval 4.17 to 6.97	4.37 Months Interval 2.83 to 7.0
Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30 Deterioration in EF domain score of ≥ 5%	6.93 Months Interval 5.55 to 8.41	6.93 Months Interval 4.17 to 7.36
Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30 Deterioration in SF domain score of ≥ 5%	8.34 Months Interval 6.93 to 10.87	7.03 Months Interval 5.62 to NA: Median time to definitive deterioration computed using Kaplan-Meier method.95% CIs calculated using Brookmeyer \& Crowley (1982) method. Therefore, upper boundary of 95% CI may not be estimable when median is close to the longest patient follow-up

SECONDARY outcome

Timeframe: 2, 4, 6, 9 months

Population: All randomized patients were included in the Full Analysis Set.

overall response = complete response (CR) + partial response (PR) per RECIST 1.0 Time to overall response (CR or PR) based on investigator is the time between date of randomization/start of treatment until first documented response (CR or PR). This analysis included all patients/responders. Patients who did not achieve a confirmed PR or CR were censored at last adequate tumor assessment date when they did not progress. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.

Outcome measures

Measure	Everolimus + Exemestane n=485 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=239 Participants Placebo of everolimus in combination with exemestane 25 mg daily
Proportion of Patients With Having no Overall Response Based on Investigator Assessment 2 months	0.96 Proportion of patients Interval 0.94 to 0.98	1.00 Proportion of patients Interval 0.97 to 1.0
Proportion of Patients With Having no Overall Response Based on Investigator Assessment 4 months	0.93 Proportion of patients Interval 0.91 to 0.95	1.00 Proportion of patients Interval 0.97 to 1.0
Proportion of Patients With Having no Overall Response Based on Investigator Assessment 6 months	0.92 Proportion of patients Interval 0.89 to 0.94	1.00 Proportion of patients Interval 0.97 to 1.0
Proportion of Patients With Having no Overall Response Based on Investigator Assessment 9 months	0.90 Proportion of patients Interval 0.88 to 0.93	1.00 Proportion of patients Interval 0.97 to 1.0

SECONDARY outcome

Timeframe: 21 months

Population: Randomized patients with best overall response of CR or PR.

Duration of response of CR or PR based on investigator applies only to patients whose best overall response was CR or PR (RECIST 1.0). The start date was the date of first documented response (CR or PR) and the end date and censoring is defined the same as that for time to progression. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.

Outcome measures

Measure	Everolimus + Exemestane n=46 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=1 Participants Placebo of everolimus in combination with exemestane 25 mg daily
Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-Meier	8.21 Months Interval 5.55 to NA - upper limit was not estimable	NA Months NA - median, lower and upper limit of the 95 % CI were not estimable

SECONDARY outcome

Timeframe: pre-dose, 2 hours post-dose

Population: Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose \& 2 hours post-dose values for the given time points were analyzed for that time point.

Characterize the pharmacokinetics (PK) of everolimus in combination with exemestane using Cmin (pre-dose) and C2h (post-dose) at week 4 in a small group of patients.

Outcome measures

Measure	Everolimus + Exemestane n=24 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane Placebo of everolimus in combination with exemestane 25 mg daily
Everolimus Concentrations at Week 4 Pre-dose (Cmin) (n:22)	16.04 ng/mL Standard Deviation 9.356	—
Everolimus Concentrations at Week 4 2 hours post-dose (C2h) (n:24)	46.50 ng/mL Standard Deviation 17.954	—

SECONDARY outcome

Timeframe: predose, 2 hours post-dose

Population: Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose \& 2 hours post-dose values for the given time points were analyzed for that time point.

Characterize the PK of exemestane in combination with or without everolimus using Cmin and C2h at week 4 in a small group of patients.

Outcome measures

Measure	Everolimus + Exemestane n=39 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=22 Participants Placebo of everolimus in combination with exemestane 25 mg daily
Exemestane Concentrations at Week 4 Pre-dose (Cmin) (n: 34, n: 22)	0.63 ng/mL Standard Deviation 0.474 • Interval 1.0 to 1.0	0.43 ng/mL Standard Deviation 0.376
Exemestane Concentrations at Week 4 2 hours post-dose (C2h) (n: 39, n: 22)	23.16 ng/mL Standard Deviation 19.805 • Interval 0.68 to 0.94	13.30 ng/mL Standard Deviation 11.889

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose \& 2 hours post-dose values for the given time points were analyzed for that time point.

Compare estradiol concentrations from baseline to week 4 in both treatment arms.

Outcome measures

Measure	Everolimus + Exemestane n=41 Participants Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=15 Participants Placebo of everolimus in combination with exemestane 25 mg daily
Estradiol Plasma Concentrations Baseline (n: = 41, 14)	5.62 pg/mL Standard Deviation 3.342 • Interval 1.0 to 1.0	4.09 pg/mL Standard Deviation 1.792
Estradiol Plasma Concentrations Week 4 (n: 38, 15)	3.50 pg/mL Standard Deviation 2.551 • Interval 0.68 to 0.94	5.17 pg/mL Standard Deviation 6.919

Adverse Events

Everolimus + Exemestane

Serious events: 158 serious events

Other events: 479 other events

Deaths: 0 deaths

Placebo + Exemestane

Serious events: 37 serious events

Other events: 209 other events

Deaths: 0 deaths

Serious adverse events

Measure	Everolimus + Exemestane n=482 participants at risk Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=238 participants at risk Placebo of everolimus in combination with exemestane 25 mg daily
Blood and lymphatic system disorders Anaemia	1.7% 8/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.84% 2/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Blood and lymphatic system disorders Neutropenia	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Blood and lymphatic system disorders Thrombocytopenia	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Arrhythmia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Atrial fibrillation	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Cardiac arrest	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Cardiac disorder	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Cardiac failure	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Cardiomyopathy	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Cardiopulmonary failure	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Sinus tachycardia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Tachyarrhythmia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Tachycardia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Abdominal distension	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Abdominal pain	1.2% 6/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Abdominal pain upper	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Ascites	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Colitis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Constipation	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Diarrhoea	0.83% 4/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Duodenal obstruction	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Dysphagia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Enterocolitis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Gastric haemorrhage	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Gastritis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Gastritis erosive	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Gastrointestinal disorder	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Intestinal perforation	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Intestinal ulcer	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Nausea	1.0% 5/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.84% 2/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Periodontitis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Rectal haemorrhage	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Small intestinal obstruction	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Stomatitis	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Vomiting	1.2% 6/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	1.3% 3/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Asthenia	1.2% 6/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Chest discomfort	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Chest pain	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Drug withdrawal syndrome	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Fatigue	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders General physical health deterioration	1.2% 6/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Hyperpyrexia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Malaise	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Non-cardiac chest pain	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Pain	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Pyrexia	1.5% 7/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	1.7% 4/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Hepatobiliary disorders Bile duct stone	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Hepatobiliary disorders Cholecystitis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Hepatobiliary disorders Cholelithiasis	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Hepatobiliary disorders Hepatic failure	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Abdominal abscess	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Bronchitis	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Bronchopneumonia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Cellulitis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Enterocolitis infectious	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Erysipelas	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Gastroenteritis	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Hepatitis C	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Herpes zoster	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Klebsiella sepsis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Lung infection	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Neutropenic sepsis	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Pneumonia	2.3% 11/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Pneumonia primary atypical	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Pyelonephritis	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Sepsis	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Staphylococcal sepsis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Upper respiratory tract infection	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Urinary tract infection	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Urinary tract infection bacterial	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	1.3% 3/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Fracture	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Overdose	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Pulmonary radiation injury	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Spinal compression fracture	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Spinal fracture	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Wound dehiscence	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Alanine aminotransferase increased	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Aspartate aminotransferase increased	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Blood creatinine increased	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Blood potassium decreased	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Computerised tomogram abnormal	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations General physical condition abnormal	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Hepatic enzyme increased	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations International normalised ratio increased	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Decreased appetite	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Dehydration	0.83% 4/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Hypercholesterolaemia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Hyperglycaemia	1.0% 5/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Hyperkalaemia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Hypokalaemia	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Hypophagia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Arthralgia	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Back pain	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Bone pain	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.84% 2/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Muscular weakness	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.84% 2/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.84% 2/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Cerebral infarction	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Convulsion	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Epilepsy	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Headache	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Hypersomnia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Hypoaesthesia	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Intracranial pressure increased	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Lethargy	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Paraparesis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Sciatica	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Spinal cord compression	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Syncope	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Transient ischaemic attack	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Tremor	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Psychiatric disorders Completed suicide	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Psychiatric disorders Confusional state	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Psychiatric disorders Delirium	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Psychiatric disorders Mental status changes	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Renal and urinary disorders Azotaemia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Renal and urinary disorders Hydronephrosis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Renal and urinary disorders Renal disorder	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Renal and urinary disorders Renal failure	1.0% 5/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Renal and urinary disorders Renal failure acute	0.83% 4/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Renal and urinary disorders Renal impairment	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Cough	0.62% 3/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.5% 12/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.84% 2/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.0% 5/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.2% 6/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.7% 13/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Productive cough	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.7% 8/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Skin and subcutaneous tissue disorders Angioedema	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Skin and subcutaneous tissue disorders Blister	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Skin and subcutaneous tissue disorders Dermatitis	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Skin and subcutaneous tissue disorders Erythema	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Skin and subcutaneous tissue disorders Pruritus	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Surgical and medical procedures Preventive surgery	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Vascular disorders Deep vein thrombosis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Vascular disorders Embolism arterial	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Vascular disorders Intra-abdominal haematoma	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Vascular disorders Ischaemia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Vascular disorders Lymphoedema	0.83% 4/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Vascular disorders Thrombophlebitis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Vascular disorders Venous thrombosis limb	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Blood and lymphatic system disorders Febrile neutropenia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Angina pectoris	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Cardiac failure congestive	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Cardiac disorders Left ventricular failure	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Eye disorders Diplopia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Eye disorders Retinal artery thrombosis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Dyspepsia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Faecaloma	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Hernial eventration	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Intestinal obstruction	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Small intestine ulcer	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Hepatobiliary disorders Cholecystitis acute	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Hepatobiliary disorders Hyperbilirubinaemia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Atypical pneumonia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Clostridium colitis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Escherichia urinary tract infection	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Groin abscess	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Histoplasmosis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Infectious colitis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Periodontitis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Pneumonia bacterial	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Pyometra	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Respiratory tract infection	0.41% 2/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Staphylococcal infection	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Fractured sacrum	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Hip fracture	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Joint dislocation	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Subdural haematoma	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Hyponatraemia	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Mobility decreased	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Pain in jaw	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Spinal pain	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to eye	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pain	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Carpal tunnel syndrome	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Dizziness	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Sensory disturbance	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Psychiatric disorders Bipolar disorder	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Psychiatric disorders Major depression	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Psychiatric disorders Mania	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Renal and urinary disorders Bladder disorder	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Skin and subcutaneous tissue disorders Skin necrosis	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Vascular disorders Accelerated hypertension	0.21% 1/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.

Other adverse events

Measure	Everolimus + Exemestane n=482 participants at risk Everolimus 10 mg daily in combination with exemestane 25 mg daily	Placebo + Exemestane n=238 participants at risk Placebo of everolimus in combination with exemestane 25 mg daily
Investigations Blood alkaline phosphatase increased	2.5% 12/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	5.0% 12/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Blood creatinine increased	7.5% 36/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.84% 2/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Blood lactate dehydrogenase increased	5.6% 27/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	1.7% 4/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Upper respiratory tract infection	6.6% 32/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	2.5% 6/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Urinary tract infection	9.3% 45/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	2.1% 5/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Alanine aminotransferase increased	11.8% 57/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	4.2% 10/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Aspartate aminotransferase increased	13.3% 64/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	5.5% 13/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Blood and lymphatic system disorders Anaemia	21.0% 101/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	4.6% 11/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Blood and lymphatic system disorders Leukopenia	6.0% 29/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	1.7% 4/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Blood and lymphatic system disorders Neutropenia	8.3% 40/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	1.7% 4/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Blood and lymphatic system disorders Thrombocytopenia	13.1% 63/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Abdominal pain upper	8.1% 39/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	2.9% 7/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Constipation	15.4% 74/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	13.0% 31/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Diarrhoea	35.7% 172/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	18.5% 44/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Dry mouth	11.4% 55/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	7.1% 17/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Nausea	32.6% 157/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	29.0% 69/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Stomatitis	59.3% 286/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	11.8% 28/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Vomiting	18.3% 88/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	12.6% 30/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Asthenia	14.5% 70/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	4.6% 11/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Fatigue	37.3% 180/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	27.3% 65/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Oedema peripheral	21.4% 103/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	6.3% 15/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
General disorders Pyrexia	17.0% 82/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	5.5% 13/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Infections and infestations Nasopharyngitis	11.0% 53/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	8.8% 21/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Gamma-glutamyltransferase increased	11.0% 53/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	8.4% 20/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Investigations Weight decreased	28.2% 136/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	7.1% 17/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Decreased appetite	30.7% 148/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	13.0% 31/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Hypercholesterolaemia	10.4% 50/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.84% 2/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Hyperglycaemia	14.3% 69/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	2.1% 5/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Hypertriglyceridaemia	6.0% 29/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	1.3% 3/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Metabolism and nutrition disorders Hypokalaemia	8.1% 39/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	1.7% 4/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Arthralgia	22.2% 107/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	17.2% 41/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Back pain	16.8% 81/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	10.5% 25/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Bone pain	6.4% 31/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	6.3% 15/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.9% 38/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	4.2% 10/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.2% 30/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	7.1% 17/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Myalgia	7.3% 35/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	6.7% 16/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Musculoskeletal and connective tissue disorders Pain in extremity	10.8% 52/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	10.9% 26/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Dizziness	7.9% 38/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	6.7% 16/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Dysgeusia	22.0% 106/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	5.9% 14/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Nervous system disorders Headache	23.2% 112/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	14.7% 35/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Psychiatric disorders Insomnia	14.1% 68/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	8.8% 21/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Cough	26.8% 129/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	11.3% 27/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	21.8% 105/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	10.5% 25/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	17.8% 86/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	1.3% 3/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.0% 29/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	2.9% 7/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Respiratory, thoracic and mediastinal disorders Pneumonitis	15.1% 73/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.00% 0/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Skin and subcutaneous tissue disorders Alopecia	10.6% 51/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	5.0% 12/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Skin and subcutaneous tissue disorders Dry skin	8.1% 39/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	1.3% 3/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Skin and subcutaneous tissue disorders Nail disorder	8.3% 40/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	0.42% 1/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Skin and subcutaneous tissue disorders Pruritus	13.3% 64/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	4.6% 11/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Skin and subcutaneous tissue disorders Rash	39.4% 190/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	6.7% 16/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Vascular disorders Hot flush	6.4% 31/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	14.3% 34/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Vascular disorders Hypertension	10.2% 49/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	3.8% 9/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Vascular disorders Lymphoedema	6.2% 30/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	1.3% 3/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Abdominal pain	5.2% 25/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	4.6% 11/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Gastrointestinal disorders Dyspepsia	6.0% 29/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	5.0% 12/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Psychiatric disorders Anxiety	5.2% 25/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	2.5% 6/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
Psychiatric disorders Depression	5.8% 28/482 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.	4.6% 11/238 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

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 in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER