Trial Outcomes & Findings for S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery (NCT NCT01120249)

NCT ID: NCT01120249

Last Updated: 2025-09-16

Results Overview

To compare 5-year recurrence-free survival in renal carcinoma participants randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy. Recurrence-free survival is defined as From date of registration to date of first documentation of recurrence or death due to any cause. Participants last known to be alive and recurrence-free are censored at date of last contact. Recurrence is defined as positive cytology or biopsy and/or progressively enlarging solid mass as evidenced by CT or MRI scans.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1545 participants
• Primary outcome timeframe: 5 years from registration
• Results posted on: 2025-09-16

Participant Flow

1545 total participants were randomly assigned; 770 on the placebo arm and 775 on the everolimus arm. 46 participants were deemed ineligible. Reasons for ineligibility include insufficient imaging or unable to rule out residual or metastatic disease, evidence of residual or metastatic disease, not intermediate-high or very-high risk, other active or recent cancer, and ineligible histology. This leaves 1499 eligible participants (744 placebo, 755 everolimus).

Participant milestones

Measure	Placebo Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.	Everolimus Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	744	755
Overall Study COMPLETED	512	343
Overall Study NOT COMPLETED	232	412

Reasons for withdrawal

Measure	Placebo Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.	Everolimus Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Overall Study No protocol treatment received	21	15
Overall Study Disease recurrence	107	57
Overall Study Death	1	0
Overall Study Adverse Event	40	276
Overall Study Participant refusal	34	42
Overall Study Other reasons, not protocol specified	29	22

Baseline Characteristics

S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery

Baseline characteristics by cohort

Measure	Placebo n=744 Participants Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.	Everolimus n=755 Participants Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.	Total n=1499 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	58 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	222 Participants n=5 Participants	235 Participants n=7 Participants	457 Participants n=5 Participants
Sex: Female, Male Male	522 Participants n=5 Participants	520 Participants n=7 Participants	1042 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	670 Participants n=5 Participants	688 Participants n=7 Participants	1358 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	27 Participants n=5 Participants	34 Participants n=7 Participants	61 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	20 Participants n=5 Participants	11 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other/unknown	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Zubrod Performance Status 0	588 Participants n=5 Participants	603 Participants n=7 Participants	1191 Participants n=5 Participants
Zubrod Performance Status 1	156 Participants n=5 Participants	152 Participants n=7 Participants	308 Participants n=5 Participants
Risk Group Intermediate-high	337 Participants n=5 Participants	343 Participants n=7 Participants	680 Participants n=5 Participants
Risk Group Very high	407 Participants n=5 Participants	412 Participants n=7 Participants	819 Participants n=5 Participants
Pathological T Stage pT1	71 Participants n=5 Participants	62 Participants n=7 Participants	133 Participants n=5 Participants
Pathological T Stage pT2	158 Participants n=5 Participants	147 Participants n=7 Participants	305 Participants n=5 Participants
Pathological T Stage pT3	498 Participants n=5 Participants	525 Participants n=7 Participants	1023 Participants n=5 Participants
Pathological T Stage pT4	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Pathological T Stage pTX	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Nephrectomy Radical	662 Participants n=5 Participants	689 Participants n=7 Participants	1351 Participants n=5 Participants
Nephrectomy Partial	82 Participants n=5 Participants	66 Participants n=7 Participants	148 Participants n=5 Participants
Histology Clear Cell	622 Participants n=5 Participants	626 Participants n=7 Participants	1248 Participants n=5 Participants
Histology Non-clear cell, Papillary	52 Participants n=5 Participants	57 Participants n=7 Participants	109 Participants n=5 Participants
Histology Non-clear cell, Chromophobe	46 Participants n=5 Participants	53 Participants n=7 Participants	99 Participants n=5 Participants
Histology Non-clear cell, Other	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Pathological Lymph Node Status pN0	220 Participants n=5 Participants	219 Participants n=7 Participants	439 Participants n=5 Participants
Pathological Lymph Node Status pN+ (fully resected)	57 Participants n=5 Participants	58 Participants n=7 Participants	115 Participants n=5 Participants
Pathological Lymph Node Status pNx (clinically N0)	467 Participants n=5 Participants	478 Participants n=7 Participants	945 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years from registration

Population: 1545 total participants were randomly assigned; 770 on the placebo arm and 775 on the everolimus arm. 46 participants were deemed ineligible. Reasons for ineligibility include insufficient imaging or unable to rule out residual or metastatic disease, evidence of residual or metastatic disease, not intermediate-high or very-high risk, other active or recent cancer, and ineligible histology. This leaves 1499 eligible participants (744 placebo, 755 everolimus).

To compare 5-year recurrence-free survival in renal carcinoma participants randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy. Recurrence-free survival is defined as From date of registration to date of first documentation of recurrence or death due to any cause. Participants last known to be alive and recurrence-free are censored at date of last contact. Recurrence is defined as positive cytology or biopsy and/or progressively enlarging solid mass as evidenced by CT or MRI scans.

Outcome measures

Measure	Placebo n=744 Participants Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.	Everolimus n=755 Participants Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
5-year Recurrence-free Survival (RFS)	63 percentage of paticipants Interval 60.0 to 67.0	67 percentage of paticipants Interval 63.0 to 70.0

SECONDARY outcome

Timeframe: 5 years from registration

Population: 1545 total participants were randomly assigned; 770 on the placebo arm and 775 on the everolimus arm. 46 participants were deemed ineligible. Reasons for ineligibility include insufficient imaging or unable to rule out residual or metastatic disease, evidence of residual or metastatic disease, not intermediate-high or very-high risk, other active or recent cancer, and ineligible histology. This leaves 1499 eligible participants (744 placebo, 755 everolimus).

To compare 5-year overall survival in those patients randomized to everolimus versus those randomized to placebo. Overall survival is defined as time from date of registration to date of death due to any cause or patients last known to be alive are censored at their last contact date.

Outcome measures

Measure	Placebo n=744 Participants Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.	Everolimus n=755 Participants Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
5-year Overall Survival (OS)	85 percentage of paticipants Interval 82.0 to 87.0	87 percentage of paticipants Interval 84.0 to 89.0

SECONDARY outcome

Timeframe: Up to 54 weeks of treatment

Population: Participants who received at least one dose of protocol treatment and were not excluded from safety analysis per the study chairs request.

Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported. Measured using CTCAE v4.0.

Outcome measures

Measure	Placebo n=723 Participants Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.	Everolimus n=740 Participants Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Frequency and Severity of Toxicities Abdominal infection	0 Participants	1 Participants
Frequency and Severity of Toxicities Abdominal pain	0 Participants	7 Participants
Frequency and Severity of Toxicities Aspartate aminotransferase increased	2 Participants	3 Participants
Frequency and Severity of Toxicities Back pain	1 Participants	2 Participants
Frequency and Severity of Toxicities Chronic kidney disease	1 Participants	3 Participants
Frequency and Severity of Toxicities Colitis	0 Participants	2 Participants
Frequency and Severity of Toxicities Dyspepsia	1 Participants	0 Participants
Frequency and Severity of Toxicities Dyspnea	1 Participants	6 Participants
Frequency and Severity of Toxicities Edema limbs	0 Participants	3 Participants
Frequency and Severity of Toxicities Fatigue	5 Participants	27 Participants
Frequency and Severity of Toxicities Gastritis	1 Participants	0 Participants
Frequency and Severity of Toxicities Gastrointestinal disorders - Other, specify	1 Participants	1 Participants
Frequency and Severity of Toxicities Glucose intolerance	0 Participants	2 Participants
Frequency and Severity of Toxicities Headache	1 Participants	2 Participants
Frequency and Severity of Toxicities Heart failure	0 Participants	2 Participants
Frequency and Severity of Toxicities Hypertriglyceridemia	13 Participants	85 Participants
Frequency and Severity of Toxicities Hyperuricemia	1 Participants	1 Participants
Frequency and Severity of Toxicities Infections and infestations - Other, specify	1 Participants	3 Participants
Frequency and Severity of Toxicities Irritability	0 Participants	1 Participants
Frequency and Severity of Toxicities Mucositis oral	2 Participants	103 Participants
Frequency and Severity of Toxicities Multi-organ failure	1 Participants	1 Participants
Frequency and Severity of Toxicities Pain in extremity	0 Participants	2 Participants
Frequency and Severity of Toxicities Peripheral sensory neuropathy	1 Participants	0 Participants
Frequency and Severity of Toxicities Photosensitivity	2 Participants	0 Participants
Frequency and Severity of Toxicities Pruritus	1 Participants	7 Participants
Frequency and Severity of Toxicities Rash acneiform	0 Participants	16 Participants
Frequency and Severity of Toxicities Rash maculo-papular	0 Participants	15 Participants
Frequency and Severity of Toxicities Seroma	0 Participants	1 Participants
Frequency and Severity of Toxicities Sinusitis	0 Participants	1 Participants
Frequency and Severity of Toxicities Skin and subcutaneous tissue disorders - Other	1 Participants	0 Participants
Frequency and Severity of Toxicities Skin infection	1 Participants	3 Participants
Frequency and Severity of Toxicities Thromboembolic event	0 Participants	4 Participants
Frequency and Severity of Toxicities Tooth infection	0 Participants	2 Participants
Frequency and Severity of Toxicities Upper respiratory infection	0 Participants	1 Participants
Frequency and Severity of Toxicities Wheezing	0 Participants	1 Participants
Frequency and Severity of Toxicities Wound infection	0 Participants	2 Participants
Frequency and Severity of Toxicities Acidosis	1 Participants	0 Participants
Frequency and Severity of Toxicities Acute kidney injury	2 Participants	2 Participants
Frequency and Severity of Toxicities Agitation	1 Participants	0 Participants
Frequency and Severity of Toxicities Alanine aminotransferase increased	3 Participants	6 Participants
Frequency and Severity of Toxicities Allergic reaction	0 Participants	1 Participants
Frequency and Severity of Toxicities Anemia	0 Participants	12 Participants
Frequency and Severity of Toxicities Anorexia	0 Participants	4 Participants
Frequency and Severity of Toxicities Aortic valve disease	0 Participants	1 Participants
Frequency and Severity of Toxicities Arthralgia	2 Participants	0 Participants
Frequency and Severity of Toxicities Bone infection	0 Participants	2 Participants
Frequency and Severity of Toxicities Bullous dermatitis	0 Participants	1 Participants
Frequency and Severity of Toxicities Cholesterol high	2 Participants	2 Participants
Frequency and Severity of Toxicities Colonic perforation	1 Participants	0 Participants
Frequency and Severity of Toxicities Creatinine increased	2 Participants	2 Participants
Frequency and Severity of Toxicities Dehydration	3 Participants	8 Participants
Frequency and Severity of Toxicities Diarrhea	5 Participants	11 Participants
Frequency and Severity of Toxicities Dizziness	1 Participants	0 Participants
Frequency and Severity of Toxicities Dry skin	0 Participants	5 Participants
Frequency and Severity of Toxicities Endocarditis infective	0 Participants	1 Participants
Frequency and Severity of Toxicities Eye disorders - Other, specify	1 Participants	0 Participants
Frequency and Severity of Toxicities Generalized muscle weakness	0 Participants	1 Participants
Frequency and Severity of Toxicities Hemorrhoids	0 Participants	1 Participants
Frequency and Severity of Toxicities Hoarseness	1 Participants	0 Participants
Frequency and Severity of Toxicities Hypercalcemia	1 Participants	1 Participants
Frequency and Severity of Toxicities Hyperglycemia	3 Participants	37 Participants
Frequency and Severity of Toxicities Hyperkalemia	1 Participants	4 Participants
Frequency and Severity of Toxicities Hypertension	20 Participants	31 Participants
Frequency and Severity of Toxicities Hypokalemia	1 Participants	0 Participants
Frequency and Severity of Toxicities Hyponatremia	1 Participants	4 Participants
Frequency and Severity of Toxicities Hypophosphatemia	1 Participants	2 Participants
Frequency and Severity of Toxicities Hypotension	0 Participants	1 Participants
Frequency and Severity of Toxicities Hypoxia	0 Participants	1 Participants
Frequency and Severity of Toxicities INR increased	0 Participants	1 Participants
Frequency and Severity of Toxicities Immune system disorders - Other, specify	0 Participants	1 Participants
Frequency and Severity of Toxicities Laryngeal mucositis	0 Participants	1 Participants
Frequency and Severity of Toxicities Leukocytosis	0 Participants	1 Participants
Frequency and Severity of Toxicities Localized edema	0 Participants	1 Participants
Frequency and Severity of Toxicities Lung infection	1 Participants	5 Participants
Frequency and Severity of Toxicities Lymphocyte count decreased	1 Participants	5 Participants
Frequency and Severity of Toxicities Myocardial infarction	0 Participants	1 Participants
Frequency and Severity of Toxicities Nail infection	0 Participants	1 Participants
Frequency and Severity of Toxicities Nausea	3 Participants	0 Participants
Frequency and Severity of Toxicities Nervous system disorders - Other, specify	0 Participants	1 Participants
Frequency and Severity of Toxicities Neutrophil count decreased	2 Participants	4 Participants
Frequency and Severity of Toxicities Non-cardiac chest pain	1 Participants	2 Participants
Frequency and Severity of Toxicities Obesity	1 Participants	1 Participants
Frequency and Severity of Toxicities Pain	0 Participants	2 Participants
Frequency and Severity of Toxicities Pneumonitis	0 Participants	9 Participants
Frequency and Severity of Toxicities Proteinuria	0 Participants	2 Participants
Frequency and Severity of Toxicities Rash pustular	0 Participants	1 Participants
Frequency and Severity of Toxicities Renal and urinary disorders - Other, specify	0 Participants	3 Participants
Frequency and Severity of Toxicities Resp, thoracic and mediastinal disorders - Other	0 Participants	3 Participants
Frequency and Severity of Toxicities Soft tissue infection	0 Participants	1 Participants
Frequency and Severity of Toxicities Syncope	2 Participants	2 Participants
Frequency and Severity of Toxicities Urinary tract infection	2 Participants	1 Participants
Frequency and Severity of Toxicities Vomiting	2 Participants	3 Participants
Frequency and Severity of Toxicities Weight gain	1 Participants	0 Participants

Adverse Events

Placebo

Serious events: 68 serious events

Other events: 649 other events

Deaths: 151 deaths

Everolimus

Serious events: 154 serious events

Other events: 716 other events

Deaths: 139 deaths

Serious adverse events

Measure	Placebo n=723 participants at risk Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Of the 770 participants assigned to this arm, 744 were eligible for efficacy analysis and included in the at-risk for all cause mortality population. The 723 participants who received placebo are included in at-risk for adverse event population.	Everolimus n=740 participants at risk Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Of the 775 participants assigned to this arm, 755 were eligible for efficacy analysis and included in the at-risk for all cause mortality population. The 740 participants who received everolimus are included in at-risk for adverse event population.
Blood and lymphatic system disorders Anemia	0.41% 3/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.1% 8/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Aortic valve disease	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Atrial fibrillation	0.41% 3/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Atrial flutter	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Atrioventricular block complete	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Cardiac arrest	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Cardiac disorders-Other	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Chest pain - cardiac	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Heart failure	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.41% 3/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Myocardial infarction	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Palpitations	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Sinus tachycardia	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Cardiac disorders Ventricular arrhythmia	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Eye disorders Blurred vision	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Eye disorders Eye disorders-Other	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Abdominal distension	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Abdominal pain	0.83% 6/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.4% 10/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Anal hemorrhage	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Colonic fistula	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Colonic obstruction	0.28% 2/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Colonic perforation	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Diarrhea	0.41% 3/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.1% 8/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Enterocolitis	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Gastric ulcer	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Gastritis	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Gastrointestinal disorders-Other	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Hemorrhoids	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Mucositis oral	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	3.0% 22/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Nausea	0.41% 3/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Pancreatitis	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Small intestinal obstruction	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Vomiting	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.68% 5/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Chills	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Edema limbs	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.41% 3/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Edema trunk	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Fatigue	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.4% 10/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Fever	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.41% 3/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders General disorders and admin site conditions - Other	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Irritability	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Localized edema	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Multi-organ failure	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Non-cardiac chest pain	0.28% 2/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.81% 6/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Pain	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Hepatobiliary disorders Cholecystitis	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Immune system disorders Allergic reaction	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Immune system disorders Immune system disorders-Other	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Abdominal infection	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Anorectal infection	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Appendicitis	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Bone infection	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Endocarditis infective	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Infections and infestations-Other	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.68% 5/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Lung infection	0.55% 4/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.81% 6/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Nail infection	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Sepsis	0.28% 2/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Skin infection	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Tooth infection	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Upper respiratory infection	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Urinary tract infection	0.55% 4/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Wound infection	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Injury, poisoning and procedural complications Ankle fracture	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Injury, poisoning and procedural complications Fracture	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Injury, poisoning and procedural complications Hip fracture	0.41% 3/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Injury, poisoning and procedural complications Injury, poison and procedural complications - Other	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Injury, poisoning and procedural complications Seroma	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Injury, poisoning and procedural complications Wound complication	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Alanine aminotransferase increased	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Aspartate aminotransferase increased	0.28% 2/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Blood bilirubin increased	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Cardiac troponin I increased	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Creatinine increased	0.55% 4/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.68% 5/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Ejection fraction decreased	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations INR increased	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Neutrophil count decreased	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Weight gain	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Weight loss	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Acidosis	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Anorexia	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Dehydration	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.95% 7/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hypercalcemia	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hyperglycemia	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.1% 8/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hyperkalemia	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hypertriglyceridemia	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	2.8% 21/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hyperuricemia	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hypokalemia	0.28% 2/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.41% 3/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Avascular necrosis	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Back pain	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Flank pain	0.28% 2/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tiss disorder - Other	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Neck pain	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Pain in extremity	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Ataxia	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Cognitive disturbance	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Dizziness	0.41% 3/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Headache	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Intracranial hemorrhage	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Memory impairment	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Nervous system disorders-Other	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Paresthesia	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Stroke	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Syncope	0.41% 3/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Transient ischemic attacks	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Psychiatric disorders Agitation	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Psychiatric disorders Confusion	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Psychiatric disorders Depression	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Psychiatric disorders Suicidal ideation	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Renal and urinary disorders Acute kidney injury	0.55% 4/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.41% 3/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Renal and urinary disorders Chronic kidney disease	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Renal and urinary disorders Proteinuria	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Renal and urinary disorders Renal and urinary disorders-Other	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Renal and urinary disorders Renal calculi	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Renal and urinary disorders Renal colic	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Renal and urinary disorders Urinary retention	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Renal and urinary disorders Urinary tract obstruction	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.41% 3/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.4% 10/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.14% 1/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.1% 8/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Resp, thoracic and mediastinal disorders - Other	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.41% 3/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.95% 7/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.27% 2/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.95% 7/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Vascular disorders Hematoma	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	0.00% 0/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Vascular disorders Hypertension	0.83% 6/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.1% 8/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Vascular disorders Thromboembolic event	0.14% 1/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.1% 8/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.

Other adverse events

Measure	Placebo n=723 participants at risk Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Of the 770 participants assigned to this arm, 744 were eligible for efficacy analysis and included in the at-risk for all cause mortality population. The 723 participants who received placebo are included in at-risk for adverse event population.	Everolimus n=740 participants at risk Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Of the 775 participants assigned to this arm, 755 were eligible for efficacy analysis and included in the at-risk for all cause mortality population. The 740 participants who received everolimus are included in at-risk for adverse event population.
Blood and lymphatic system disorders Anemia	20.9% 151/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	49.2% 364/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Abdominal pain	15.4% 111/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	18.5% 137/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Constipation	11.9% 86/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	11.6% 86/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Diarrhea	20.1% 145/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	39.1% 289/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Dry mouth	5.1% 37/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	7.4% 55/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Dyspepsia	6.4% 46/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	3.9% 29/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Mucositis oral	19.8% 143/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	64.1% 474/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Nausea	20.6% 149/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	28.1% 208/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Gastrointestinal disorders Vomiting	6.9% 50/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	12.2% 90/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Chills	3.5% 25/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	7.4% 55/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Edema limbs	10.7% 77/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	23.0% 170/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Fatigue	50.6% 366/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	60.7% 449/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Fever	2.8% 20/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	8.2% 61/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
General disorders Pain	11.6% 84/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	11.8% 87/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Skin infection	2.9% 21/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	6.1% 45/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Infections and infestations Upper respiratory infection	6.1% 44/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	6.4% 47/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Alanine aminotransferase increased	9.5% 69/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	19.3% 143/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Alkaline phosphatase increased	7.7% 56/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	14.1% 104/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Aspartate aminotransferase increased	9.0% 65/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	21.5% 159/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Blood bilirubin increased	5.5% 40/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	1.6% 12/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Cholesterol high	24.9% 180/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	53.5% 396/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Creatinine increased	38.7% 280/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	43.6% 323/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Lymphocyte count decreased	3.7% 27/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	12.6% 93/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Neutrophil count decreased	2.9% 21/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	8.8% 65/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Platelet count decreased	5.7% 41/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	18.8% 139/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Weight gain	11.3% 82/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	4.5% 33/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations Weight loss	2.4% 17/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	11.1% 82/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Investigations White blood cell decreased	5.7% 41/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	16.9% 125/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Anorexia	6.6% 48/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	18.1% 134/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hyperglycemia	37.1% 268/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	43.1% 319/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hyperkalemia	9.4% 68/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	5.8% 43/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hypertriglyceridemia	40.8% 295/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	56.6% 419/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hypoalbuminemia	2.4% 17/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	8.0% 59/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hypocalcemia	3.7% 27/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	10.1% 75/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hypokalemia	2.2% 16/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	6.6% 49/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Metabolism and nutrition disorders Hyponatremia	7.2% 52/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	8.4% 62/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Arthralgia	16.3% 118/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	13.1% 97/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Back pain	17.2% 124/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	13.1% 97/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Flank pain	7.6% 55/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	5.3% 39/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Myalgia	7.6% 55/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	10.0% 74/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Musculoskeletal and connective tissue disorders Pain in extremity	12.4% 90/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	11.6% 86/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Dizziness	14.4% 104/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	15.1% 112/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Dysgeusia	6.6% 48/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	21.5% 159/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Headache	21.6% 156/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	28.9% 214/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Nervous system disorders Peripheral sensory neuropathy	7.3% 53/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	5.5% 41/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Psychiatric disorders Anxiety	8.3% 60/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	5.4% 40/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Psychiatric disorders Depression	5.8% 42/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	4.3% 32/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Psychiatric disorders Insomnia	11.6% 84/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	11.6% 86/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Renal and urinary disorders Urinary frequency	5.1% 37/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	6.2% 46/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Cough	22.4% 162/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	27.6% 204/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 80/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	21.1% 156/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.4% 17/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	17.0% 126/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.2% 45/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	9.9% 73/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.55% 4/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	13.1% 97/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Respiratory, thoracic and mediastinal disorders Sore throat	3.0% 22/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	9.5% 70/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Dry skin	10.7% 77/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	19.5% 144/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Erythema multiforme	1.7% 12/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	5.0% 37/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Pruritus	11.1% 80/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	19.9% 147/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Rash acneiform	6.9% 50/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	29.5% 218/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.7% 70/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	32.8% 243/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	7.3% 53/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	10.8% 80/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
Vascular disorders Hypertension	27.0% 195/723 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.	26.6% 197/740 • Duration of treatment and follow up until death or 10 years post registration 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.

Additional Information

Melissa Plets

SWOG

Phone: 206.667.2707

Email: mplets@fredhutch.org

Results disclosure agreements

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

Restriction type: LTE60