Trial Outcomes & Findings for S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer (NCT NCT01674140)
NCT ID: NCT01674140
Last Updated: 2024-12-27
Results Overview
Time from date of registration to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. The results were presented as 5-year IDFS estimate.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
1939 participants
Primary outcome timeframe
Up to 5 years post registration
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Placebo
Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity.
NOTE: \*Men receive tamoxifen citrate PO for 5 years. NOTE: \*\*Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal.
|
Everolimus
Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
968
|
971
|
|
Overall Study
COMPLETED
|
896
|
896
|
|
Overall Study
NOT COMPLETED
|
72
|
75
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
Placebo
n=896 Participants
Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity.
NOTE: \*Men receive tamoxifen citrate PO for 5 years. NOTE: \*\*Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal.
|
Everolimus
n=896 Participants
Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
|
Total
n=1792 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
54 years
n=5 Participants
|
54 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
888 Participants
n=5 Participants
|
893 Participants
n=7 Participants
|
1781 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
757 Participants
n=5 Participants
|
772 Participants
n=7 Participants
|
1529 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
58 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
82 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
791 Participants
n=5 Participants
|
785 Participants
n=7 Participants
|
1576 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Risk Group
Node-negative and RS > 25 or High Risk
|
79 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Risk Group
MammaPrint tx w/ adjuvant chemo(AC) 1-3 LN+ & RS>25 or High Risk MammaPrint or Grd3 disease tx w/ AC
|
107 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Risk Group
≥ 4 positive lymph nodes (any RS value) treated with adjuvant chemo
|
357 Participants
n=5 Participants
|
353 Participants
n=7 Participants
|
710 Participants
n=5 Participants
|
|
Risk Group
≥ 1 positive lymph node (any RS value) after neoadjuvant chemo
|
353 Participants
n=5 Participants
|
358 Participants
n=7 Participants
|
711 Participants
n=5 Participants
|
|
Menopausal Status
Pre-Menopausal
|
290 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
571 Participants
n=5 Participants
|
|
Menopausal Status
Post-Menopausal
|
606 Participants
n=5 Participants
|
615 Participants
n=7 Participants
|
1221 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
710 Participants
n=5 Participants
|
701 Participants
n=7 Participants
|
1411 Participants
n=5 Participants
|
|
ECOG Performance Status
1-2
|
185 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
379 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 years post registrationPopulation: The analysis population includes the 1792 participants who were eligible and evaluable (896 per arm).
Time from date of registration to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. The results were presented as 5-year IDFS estimate.
Outcome measures
| Measure |
Placebo
n=896 Participants
Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity.
NOTE: \*Men receive tamoxifen citrate PO for 5 years. NOTE: \*\*Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal.
|
Everolimus
n=896 Participants
Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Invasive Disease-Free Survival (IDFS)
|
74.4 percentage of participants
Interval 71.1 to 77.4
|
74.9 percentage of participants
Interval 71.3 to 78.0
|
SECONDARY outcome
Timeframe: 5 years after last accrualPopulation: The analysis population includes the 1792 participants who were eligible and evaluable (896 per arm).
Time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date. The results were presented as 5-year OS estimate.
Outcome measures
| Measure |
Placebo
n=896 Participants
Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity.
NOTE: \*Men receive tamoxifen citrate PO for 5 years. NOTE: \*\*Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal.
|
Everolimus
n=896 Participants
Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
85.8 percentage of participants
Interval 82.9 to 88.2
|
88.1 percentage of participants
Interval 85.3 to 90.3
|
SECONDARY outcome
Timeframe: Every 6 weeks while on protocol therapy. Adverse events (AEs) that occurred during follow up after protocol treatment were reported as late AEs, for every 6 months for the first 2 years and then yearly until 10 years after registration.Population: Limited to participants who started treatment, and were evaluated for toxicity assessment.
Toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only adverse events that are possibly, probably, or definitely related to study drug are reported.
Outcome measures
| Measure |
Placebo
n=881 Participants
Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity.
NOTE: \*Men receive tamoxifen citrate PO for 5 years. NOTE: \*\*Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal.
|
Everolimus
n=874 Participants
Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Kidney infection
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Left ventricular systolic dysfunction
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Back pain
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Bone pain
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Edema face
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Hypokalemia
|
0 Participants
|
5 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Lung infection
|
2 Participants
|
6 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Lymphedema
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Paroxysmal atrial tachycardia
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Periorbital edema
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Rash pustular
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Sepsis
|
0 Participants
|
7 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Seroma
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Skin and subcutaneous tissue disorders - Other
|
0 Participants
|
3 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Skin infection
|
3 Participants
|
8 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Soft tissue infection
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Urinary tract infection
|
1 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Vascular access complication
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Abdominal pain
|
1 Participants
|
7 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Alanine aminotransferase increased
|
1 Participants
|
4 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Allergic reaction
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Anemia
|
0 Participants
|
10 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Anxiety
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Appendicitis
|
2 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Appendicitis perforated
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Arthralgia
|
1 Participants
|
5 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Ascites
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Aspartate aminotransferase increased
|
1 Participants
|
6 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Breast infection
|
1 Participants
|
6 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Cardiac arrest
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Cholecystitis
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Cholesterol high
|
0 Participants
|
9 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Colitis
|
1 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Cough
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Dehydration
|
0 Participants
|
3 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Depression
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Diarrhea
|
3 Participants
|
13 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Dizziness
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Dyspnea
|
2 Participants
|
7 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Edema limbs
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Eye disorders - Other, specify
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Eye infection
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Fatigue
|
6 Participants
|
23 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Fever
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Gallbladder infection
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Gallbladder perforation
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Gastrointestinal disorders - Other, specify
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
General disorders and admin site conditions - Other
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Generalized muscle weakness
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Headache
|
1 Participants
|
4 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Heart failure
|
0 Participants
|
4 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Hip fracture
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Hot flashes
|
2 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Hyperglycemia
|
1 Participants
|
33 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Hyperhidrosis
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Hyperkalemia
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Hypertension
|
6 Participants
|
15 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Hypertriglyceridemia
|
4 Participants
|
35 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Hyponatremia
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Hypophosphatemia
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Hypoxia
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Immune system disorders - Other, specify
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Infections and infestations - Other, specify
|
4 Participants
|
5 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Infusion related reaction
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Insomnia
|
0 Participants
|
3 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Investigations - Other, specify
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Irregular menstruation
|
1 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Joint infection
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Lipase increased
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Lymphocyte count decreased
|
5 Participants
|
36 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Menorrhagia
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Mucositis oral
|
2 Participants
|
60 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Muscle weakness lower limb
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Muscle weakness upper limb
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Musculoskeletal and connective tiss disorder - Other
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Myalgia
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Nasal congestion
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Nausea
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Neck pain
|
1 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Nervous system disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Neuralgia
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Neutrophil count decreased
|
3 Participants
|
22 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Obesity
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Otitis media
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Pain
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Pain in extremity
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Papulopustular rash
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Peripheral sensory neuropathy
|
1 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Platelet count decreased
|
1 Participants
|
4 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Pleural effusion
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Pneumonitis
|
1 Participants
|
7 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Portal vein thrombosis
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Postoperative hemorrhage
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Productive cough
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Pruritus
|
1 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Psychiatric disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Pulmonary edema
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Radiation recall reaction (dermatologic)
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Rash acneiform
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Rash maculo-papular
|
0 Participants
|
4 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Respiratory failure
|
1 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Skin ulceration
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Sore throat
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Suicidal ideation
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Suicide attempt
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Thromboembolic event
|
3 Participants
|
5 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Tooth infection
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Upper respiratory infection
|
0 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Vomiting
|
1 Participants
|
1 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Weight gain
|
2 Participants
|
0 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Weight loss
|
0 Participants
|
2 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
White blood cell decreased
|
2 Participants
|
20 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Wound complication
|
0 Participants
|
5 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Wound dehiscence
|
1 Participants
|
4 Participants
|
|
Toxicity Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, Assessed up to 10 Years.
Wound infection
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 5 years after last accrualTime from date of registration to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Patients last known to be alive who have not experienced distant recurrence, or second primary cancer are censored at their last contact date. The results were presented as 5-year DRFS estimate.
Outcome measures
| Measure |
Placebo
n=896 Participants
Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity.
NOTE: \*Men receive tamoxifen citrate PO for 5 years. NOTE: \*\*Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal.
|
Everolimus
n=896 Participants
Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Distant Recurrence-Free Survival (DRFS)
|
75.7 percentage of participants
Interval 72.4 to 78.7
|
76.9 percentage of participants
Interval 73.5 to 80.0
|
Adverse Events
Placebo
Serious events: 77 serious events
Other events: 798 other events
Deaths: 119 deaths
Everolimus
Serious events: 180 serious events
Other events: 842 other events
Deaths: 112 deaths
Serious adverse events
| Measure |
Placebo
n=881 participants at risk
Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity.
NOTE: \*Men receive tamoxifen citrate PO for 5 years. NOTE: \*\*Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal.
|
Everolimus
n=874 participants at risk
Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.34%
3/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.80%
7/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.34%
3/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Cardiac disorders
Cardiac arrest
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Cardiac disorders
Cardiac disorders-Other
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.69%
6/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.34%
3/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Eye disorders
Eye disorders-Other
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Eye disorders
Glaucoma
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.57%
5/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.92%
8/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.34%
3/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.80%
7/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.34%
3/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
1.3%
11/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.34%
3/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.34%
3/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.57%
5/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Edema face
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Edema limbs
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Fatigue
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.80%
7/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Fever
|
0.34%
3/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.69%
6/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Flu like symptoms
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
General disorders and admin site conditions - Other
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Infusion related reaction
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Localized edema
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Malaise
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Pain
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Sudden death NOS
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.46%
4/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.57%
5/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Immune system disorders
Immune system disorders-Other
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Appendicitis
|
0.34%
3/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Breast infection
|
0.91%
8/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
1.6%
14/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Device related infection
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Gallbladder infection
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Infections and infestations-Other
|
0.57%
5/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
1.1%
10/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Joint infection
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Lung infection
|
0.34%
3/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
1.5%
13/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Otitis media
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Sepsis
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.80%
7/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Skin infection
|
0.91%
8/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
1.8%
16/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Wound infection
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.92%
8/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Injury, poison and procedural complications - Other
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.46%
4/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.34%
3/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.34%
3/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Blood bilirubin increased
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Cardiac troponin I increased
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Cholesterol high
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.57%
5/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Creatinine increased
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.34%
3/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.46%
4/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Platelet count decreased
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.57%
5/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Weight loss
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
White blood cell decreased
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.46%
4/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.57%
5/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
1.3%
11/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.34%
3/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
1.0%
9/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.80%
7/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Ataxia
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Dizziness
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Headache
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.46%
4/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Memory impairment
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Nervous system disorders-Other
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Stroke
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Syncope
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Psychiatric disorders
Confusion
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Psychiatric disorders
Depression
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Psychiatric disorders
Psychiatric disorders-Other
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Psychiatric disorders
Psychosis
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Psychiatric disorders
Suicidal ideation
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Reproductive system and breast disorders
Breast pain
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.34%
3/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.34%
3/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
1.1%
10/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
1.4%
12/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.23%
2/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
0.45%
4/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.57%
5/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.11%
1/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Vascular disorders
Hematoma
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.34%
3/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Vascular disorders
Hypertension
|
0.34%
3/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.46%
4/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Vascular disorders
Hypotension
|
0.11%
1/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.00%
0/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.23%
2/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Vascular disorders
Thromboembolic event
|
0.45%
4/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
0.92%
8/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
Other adverse events
| Measure |
Placebo
n=881 participants at risk
Patients receive an approved endocrine therapy comprising tamoxifen citrate\*, goserelin acetate\*\* or leuprolide acetate\*\*, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity.
NOTE: \*Men receive tamoxifen citrate PO for 5 years. NOTE: \*\*Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal.
|
Everolimus
n=874 participants at risk
Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.5%
75/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
27.3%
239/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
64/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
8.0%
70/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Constipation
|
13.8%
122/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
12.1%
106/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
17.3%
152/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
26.0%
227/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
53/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
10.1%
88/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Mucositis oral
|
24.2%
213/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
59.4%
519/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Nausea
|
20.2%
178/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
25.3%
221/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Oral pain
|
3.1%
27/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
5.3%
46/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
51/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
9.5%
83/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Edema limbs
|
9.9%
87/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
19.6%
171/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Fatigue
|
42.0%
370/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
47.4%
414/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Fever
|
3.7%
33/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
7.4%
65/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
General disorders
Pain
|
16.3%
144/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
12.8%
112/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Infections and infestations-Other
|
4.8%
42/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
6.2%
54/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Skin infection
|
2.3%
20/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
5.7%
50/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Upper respiratory infection
|
5.1%
45/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
6.2%
54/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Infections and infestations
Urinary tract infection
|
4.4%
39/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
6.4%
56/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
47/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
17.0%
149/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Alkaline phosphatase increased
|
7.2%
63/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
10.1%
88/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
54/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
20.7%
181/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Cholesterol high
|
22.8%
201/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
44.5%
389/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Lymphocyte count decreased
|
10.4%
92/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
20.9%
183/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Neutrophil count decreased
|
7.0%
62/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
15.8%
138/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Platelet count decreased
|
4.0%
35/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
14.0%
122/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Weight gain
|
6.1%
54/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
2.4%
21/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
Weight loss
|
3.9%
34/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
11.4%
100/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Investigations
White blood cell decreased
|
14.8%
130/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
31.1%
272/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
49/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
12.7%
111/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.3%
152/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
29.7%
260/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
16.7%
147/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
34.6%
302/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.5%
31/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
7.8%
68/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.68%
6/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
5.1%
45/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.4%
30/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
9.8%
86/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
32.9%
290/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
25.4%
222/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
101/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
9.0%
79/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.4%
48/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
4.1%
36/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
6.9%
61/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
4.3%
38/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.8%
113/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
12.7%
111/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.3%
161/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
15.1%
132/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Dizziness
|
12.0%
106/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
11.0%
96/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Dysgeusia
|
4.0%
35/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
14.8%
129/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Headache
|
21.1%
186/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
28.6%
250/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.5%
163/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
15.2%
133/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Psychiatric disorders
Anxiety
|
10.3%
91/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
9.6%
84/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Psychiatric disorders
Depression
|
9.0%
79/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
8.0%
70/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Psychiatric disorders
Insomnia
|
18.4%
162/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
16.8%
147/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Reproductive system and breast disorders
Breast pain
|
5.3%
47/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
6.3%
55/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.4%
162/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
25.5%
223/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.4%
83/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
14.0%
122/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
12/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
8.7%
76/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.3%
38/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
6.6%
58/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.3%
38/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
7.4%
65/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.2%
46/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
7.8%
68/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
66/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
9.3%
81/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.4%
30/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
10.4%
91/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
80/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
21.7%
190/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
9.1%
80/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
9.5%
83/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Vascular disorders
Hot flashes
|
34.1%
300/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
24.8%
217/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Vascular disorders
Hypertension
|
13.6%
120/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
18.9%
165/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
|
Vascular disorders
Lymphedema
|
10.8%
95/881 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
17.8%
156/874 • Every 6 weeks while on protocol treatment. Once after protocol treatment, it is reported as late adverse events for every 6 months for first 2 years, then annually until 10 years from registration.
CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. There were 874 participants in the everolimus and endocrine arm that were assessed for AEs and 881 participants in the placebo and endocrine arm that were assessed for AEs.
|
Additional Information
Breast Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place