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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01120249
Recruitment Status : Active, not recruiting
First Posted : May 10, 2010
Results First Posted : March 20, 2024
Last Update Posted : March 20, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
SWOG Cancer Research Network

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Kidney Cancer
Interventions Drug: everolimus
Other: placebo
Enrollment 1545
Recruitment Details  
Pre-assignment Details 1545 total participants were randomly assigned; 770 on the placebo arm and 775 on the everolimus arm. 46 participants were deemed ineligible. Reasons for ineligibility include insufficient imaging or unable to rule out residual or metastatic disease, evidence of residual or metastatic disease, not intermediate-high or very-high risk, other active or recent cancer, and ineligible histology. This leaves 1499 eligible participants (744 placebo, 755 everolimus).
Arm/Group Title Placebo Everolimus
Hide Arm/Group Description Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 744 755
Completed 512 343
Not Completed 232 412
Reason Not Completed
No protocol treatment received             21             15
Disease recurrence             107             57
Death             1             0
Adverse Event             40             276
Participant refusal             34             42
Other reasons, not protocol specified             29             22
Arm/Group Title Placebo Everolimus Total
Hide Arm/Group Description Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 744 755 1499
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 744 participants 755 participants 1499 participants
58
(50 to 66)
58
(51 to 66)
58
(51 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 744 participants 755 participants 1499 participants
Female
222
  29.8%
235
  31.1%
457
  30.5%
Male
522
  70.2%
520
  68.9%
1042
  69.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 744 participants 755 participants 1499 participants
White
670
  90.1%
688
  91.1%
1358
  90.6%
Black
27
   3.6%
34
   4.5%
61
   4.1%
Asian
20
   2.7%
11
   1.5%
31
   2.1%
Other/unknown
27
   3.6%
22
   2.9%
49
   3.3%
Zubrod Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 744 participants 755 participants 1499 participants
0
588
  79.0%
603
  79.9%
1191
  79.5%
1
156
  21.0%
152
  20.1%
308
  20.5%
[1]
Measure Description:

A performance status of 0 is defined as fully active, able to carry on all pre-disease performance without restriction.

A performance status of 1 is defined as restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
Risk Group  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 744 participants 755 participants 1499 participants
Intermediate-high
337
  45.3%
343
  45.4%
680
  45.4%
Very high
407
  54.7%
412
  54.6%
819
  54.6%
Pathological T Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 744 participants 755 participants 1499 participants
pT1
71
   9.5%
62
   8.2%
133
   8.9%
pT2
158
  21.2%
147
  19.5%
305
  20.3%
pT3
498
  66.9%
525
  69.5%
1023
  68.2%
pT4
14
   1.9%
17
   2.3%
31
   2.1%
pTX
3
   0.4%
4
   0.5%
7
   0.5%
[1]
Measure Description: pT1 - Tumor invades subepithelial connective tissue pT2 - Tumor invades muscularis pT3 - Tumor invades beyond muscularis into: peripelvic fat and renal parenchyma pT4 - Tumor invades adjacent organs OR through the kidney into perinephric fat pTX- Primary tumor cannot be assessed
Nephrectomy  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 744 participants 755 participants 1499 participants
Radical
662
  89.0%
689
  91.3%
1351
  90.1%
Partial
82
  11.0%
66
   8.7%
148
   9.9%
Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 744 participants 755 participants 1499 participants
Clear Cell
622
  83.6%
626
  82.9%
1248
  83.3%
Non-clear cell, Papillary
52
   7.0%
57
   7.5%
109
   7.3%
Non-clear cell, Chromophobe
46
   6.2%
53
   7.0%
99
   6.6%
Non-clear cell, Other
24
   3.2%
19
   2.5%
43
   2.9%
Pathological Lymph Node Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 744 participants 755 participants 1499 participants
pN0
220
  29.6%
219
  29.0%
439
  29.3%
pN+ (fully resected)
57
   7.7%
58
   7.7%
115
   7.7%
pNx (clinically N0)
467
  62.8%
478
  63.3%
945
  63.0%
[1]
Measure Description: pN0 - No regional lymph node metastasis pN+ (fully resected) - Metastasis in regional lymph node(s) pNx (clinically N0) - Regional lymph nodes cannot be assessed
1.Primary Outcome
Title 5-year Recurrence-free Survival (RFS)
Hide Description To compare 5-year recurrence-free survival in renal carcinoma participants randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy. Recurrence-free survival is defined as From date of registration to date of first documentation of recurrence or death due to any cause. Participants last known to be alive and recurrence-free are censored at date of last contact. Recurrence is defined as positive cytology or biopsy and/or progressively enlarging solid mass as evidenced by CT or MRI scans.
Time Frame 5 years from registration
Hide Outcome Measure Data
Hide Analysis Population Description
1545 total participants were randomly assigned; 770 on the placebo arm and 775 on the everolimus arm. 46 participants were deemed ineligible. Reasons for ineligibility include insufficient imaging or unable to rule out residual or metastatic disease, evidence of residual or metastatic disease, not intermediate-high or very-high risk, other active or recent cancer, and ineligible histology. This leaves 1499 eligible participants (744 placebo, 755 everolimus).
Arm/Group Title Placebo Everolimus
Hide Arm/Group Description:
Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 744 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of paticipants
63
(60 to 67)
67
(63 to 70)
2.Secondary Outcome
Title 5-year Overall Survival (OS)
Hide Description To compare 5-year overall survival in those patients randomized to everolimus versus those randomized to placebo. Overall survival is defined as time from date of registration to date of death due to any cause or patients last known to be alive are censored at their last contact date.
Time Frame 5 years from registration
Hide Outcome Measure Data
Hide Analysis Population Description
1545 total participants were randomly assigned; 770 on the placebo arm and 775 on the everolimus arm. 46 participants were deemed ineligible. Reasons for ineligibility include insufficient imaging or unable to rule out residual or metastatic disease, evidence of residual or metastatic disease, not intermediate-high or very-high risk, other active or recent cancer, and ineligible histology. This leaves 1499 eligible participants (744 placebo, 755 everolimus).
Arm/Group Title Placebo Everolimus
Hide Arm/Group Description:
Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 744 755
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of paticipants
85
(82 to 87)
87
(84 to 89)
3.Secondary Outcome
Title Frequency and Severity of Toxicities
Hide Description Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported. Measured using CTCAE v4.0.
Time Frame Up to 54 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of protocol treatment and were not excluded from safety analysis per the study chairs request.
Arm/Group Title Placebo Everolimus
Hide Arm/Group Description:
Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oral Everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 723 740
Measure Type: Number
Unit of Measure: Participants
Abdominal infection 0 1
Abdominal pain 0 7
Acidosis 1 0
Acute kidney injury 2 2
Agitation 1 0
Alanine aminotransferase increased 3 6
Allergic reaction 0 1
Anemia 0 12
Anorexia 0 4
Aortic valve disease 0 1
Arthralgia 2 0
Aspartate aminotransferase increased 2 3
Back pain 1 2
Bone infection 0 2
Bullous dermatitis 0 1
Cholesterol high 2 2
Chronic kidney disease 1 3
Colitis 0 2
Colonic perforation 1 0
Creatinine increased 2 2
Dehydration 3 8
Diarrhea 5 11
Dizziness 1 0
Dry skin 0 5
Dyspepsia 1 0
Dyspnea 1 6
Edema limbs 0 3
Endocarditis infective 0 1
Eye disorders - Other, specify 1 0
Fatigue 5 27
Gastritis 1 0
Gastrointestinal disorders - Other, specify 1 1
Generalized muscle weakness 0 1
Glucose intolerance 0 2
Headache 1 2
Heart failure 0 2
Hemorrhoids 0 1
Hoarseness 1 0
Hypercalcemia 1 1
Hyperglycemia 3 37
Hyperkalemia 1 4
Hypertension 20 31
Hypertriglyceridemia 13 85
Hyperuricemia 1 1
Hypokalemia 1 0
Hyponatremia 1 4
Hypophosphatemia 1 2
Hypotension 0 1
Hypoxia 0 1
INR increased 0 1
Immune system disorders - Other, specify 0 1
Infections and infestations - Other, specify 1 3
Irritability 0 1
Laryngeal mucositis 0 1
Leukocytosis 0 1
Localized edema 0 1
Lung infection 1 5
Lymphocyte count decreased 1 5
Mucositis oral 2 103
Multi-organ failure 1 1
Myocardial infarction 0 1
Nail infection 0 1
Nausea 3 0
Nervous system disorders - Other, specify 0 1
Neutrophil count decreased 2 4
Non-cardiac chest pain 1 2
Obesity 1 1
Pain 0 2
Pain in extremity 0 2
Peripheral sensory neuropathy 1 0
Photosensitivity 2 0
Pneumonitis 0 9
Proteinuria 0 2
Pruritus 1 7
Rash acneiform 0 16
Rash maculo-papular 0 15
Rash pustular 0 1
Renal and urinary disorders - Other, specify 0 3
Resp, thoracic and mediastinal disorders - Other 0 3
Seroma 0 1
Sinusitis 0 1
Skin and subcutaneous tissue disorders - Other 1 0
Skin infection 1 3
Soft tissue infection 0 1
Syncope 2 2
Thromboembolic event 0 4
Tooth infection 0 2
Upper respiratory infection 0 1
Urinary tract infection 2 1
Vomiting 2 3
Weight gain 1 0
Wheezing 0 1
Wound infection 0 2
Time Frame Duration of treatment and follow up until death or 10 years post registration
Adverse Event Reporting Description 1,463 eligible participants who received at least one dose of protocol treatment were evaluable for Adverse Events (AEs): 740 on the Everolimus arm and 723 on the placebo arm. AEs and Serious Adverse Events (SAEs) are reported by CTCAE Version 4.0.
 
Arm/Group Title Placebo Everolimus
Hide Arm/Group Description Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Of the 770 participants assigned to this arm, 744 were eligible for efficacy analysis and included in the at-risk for all cause mortality population. The 723 participants who received placebo are included in at-risk for adverse event population. Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Of the 775 participants assigned to this arm, 755 were eligible for efficacy analysis and included in the at-risk for all cause mortality population. The 740 participants who received everolimus are included in at-risk for adverse event population.
All-Cause Mortality
Placebo Everolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   151/744 (20.30%)   139/755 (18.41%) 
Hide Serious Adverse Events
Placebo Everolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   68/723 (9.41%)   154/740 (20.81%) 
Blood and lymphatic system disorders     
Anemia †  3/723 (0.41%)  8/740 (1.08%) 
Cardiac disorders     
Aortic valve disease †  1/723 (0.14%)  1/740 (0.14%) 
Atrial fibrillation †  3/723 (0.41%)  1/740 (0.14%) 
Atrial flutter †  1/723 (0.14%)  0/740 (0.00%) 
Atrioventricular block complete †  1/723 (0.14%)  1/740 (0.14%) 
Cardiac arrest †  0/723 (0.00%)  1/740 (0.14%) 
Cardiac disorders-Other †  1/723 (0.14%)  1/740 (0.14%) 
Chest pain - cardiac †  1/723 (0.14%)  2/740 (0.27%) 
Heart failure †  1/723 (0.14%)  3/740 (0.41%) 
Myocardial infarction †  1/723 (0.14%)  1/740 (0.14%) 
Palpitations †  0/723 (0.00%)  2/740 (0.27%) 
Sinus tachycardia †  1/723 (0.14%)  2/740 (0.27%) 
Ventricular arrhythmia †  0/723 (0.00%)  1/740 (0.14%) 
Eye disorders     
Blurred vision †  1/723 (0.14%)  0/740 (0.00%) 
Eye disorders-Other †  1/723 (0.14%)  0/740 (0.00%) 
Gastrointestinal disorders     
Abdominal distension †  1/723 (0.14%)  0/740 (0.00%) 
Abdominal pain †  6/723 (0.83%)  10/740 (1.35%) 
Anal hemorrhage †  1/723 (0.14%)  0/740 (0.00%) 
Colonic fistula †  1/723 (0.14%)  0/740 (0.00%) 
Colonic obstruction †  2/723 (0.28%)  0/740 (0.00%) 
Colonic perforation †  1/723 (0.14%)  0/740 (0.00%) 
Diarrhea †  3/723 (0.41%)  8/740 (1.08%) 
Enterocolitis †  0/723 (0.00%)  1/740 (0.14%) 
Gastric hemorrhage †  0/723 (0.00%)  1/740 (0.14%) 
Gastric ulcer †  0/723 (0.00%)  1/740 (0.14%) 
Gastritis †  1/723 (0.14%)  0/740 (0.00%) 
Gastrointestinal disorders-Other †  1/723 (0.14%)  0/740 (0.00%) 
Hemorrhoidal hemorrhage †  0/723 (0.00%)  1/740 (0.14%) 
Hemorrhoids †  0/723 (0.00%)  1/740 (0.14%) 
Mucositis oral †  0/723 (0.00%)  22/740 (2.97%) 
Nausea †  3/723 (0.41%)  1/740 (0.14%) 
Pancreatitis †  0/723 (0.00%)  1/740 (0.14%) 
Small intestinal obstruction †  1/723 (0.14%)  2/740 (0.27%) 
Upper gastrointestinal hemorrhage †  0/723 (0.00%)  1/740 (0.14%) 
Vomiting †  1/723 (0.14%)  5/740 (0.68%) 
General disorders     
Chills †  0/723 (0.00%)  1/740 (0.14%) 
Edema limbs †  1/723 (0.14%)  3/740 (0.41%) 
Edema trunk †  1/723 (0.14%)  0/740 (0.00%) 
Fatigue †  1/723 (0.14%)  10/740 (1.35%) 
Fever †  1/723 (0.14%)  3/740 (0.41%) 
General disorders and admin site conditions - Other †  0/723 (0.00%)  2/740 (0.27%) 
Irritability †  0/723 (0.00%)  1/740 (0.14%) 
Localized edema †  0/723 (0.00%)  1/740 (0.14%) 
Multi-organ failure †  1/723 (0.14%)  0/740 (0.00%) 
Non-cardiac chest pain †  2/723 (0.28%)  6/740 (0.81%) 
Pain †  0/723 (0.00%)  1/740 (0.14%) 
Hepatobiliary disorders     
Cholecystitis †  1/723 (0.14%)  1/740 (0.14%) 
Immune system disorders     
Allergic reaction †  0/723 (0.00%)  1/740 (0.14%) 
Immune system disorders-Other †  0/723 (0.00%)  1/740 (0.14%) 
Infections and infestations     
Abdominal infection †  1/723 (0.14%)  0/740 (0.00%) 
Anorectal infection †  0/723 (0.00%)  1/740 (0.14%) 
Appendicitis †  0/723 (0.00%)  1/740 (0.14%) 
Bone infection †  0/723 (0.00%)  2/740 (0.27%) 
Endocarditis infective †  0/723 (0.00%)  1/740 (0.14%) 
Infections and infestations-Other †  1/723 (0.14%)  5/740 (0.68%) 
Lung infection †  4/723 (0.55%)  6/740 (0.81%) 
Nail infection †  0/723 (0.00%)  1/740 (0.14%) 
Sepsis †  2/723 (0.28%)  0/740 (0.00%) 
Skin infection †  1/723 (0.14%)  2/740 (0.27%) 
Tooth infection †  0/723 (0.00%)  2/740 (0.27%) 
Upper respiratory infection †  0/723 (0.00%)  2/740 (0.27%) 
Urinary tract infection †  4/723 (0.55%)  0/740 (0.00%) 
Wound infection †  0/723 (0.00%)  1/740 (0.14%) 
Injury, poisoning and procedural complications     
Ankle fracture †  1/723 (0.14%)  0/740 (0.00%) 
Fracture †  1/723 (0.14%)  0/740 (0.00%) 
Hip fracture †  3/723 (0.41%)  0/740 (0.00%) 
Injury, poison and procedural complications - Other †  1/723 (0.14%)  0/740 (0.00%) 
Seroma †  0/723 (0.00%)  1/740 (0.14%) 
Wound complication †  0/723 (0.00%)  1/740 (0.14%) 
Investigations     
Alanine aminotransferase increased †  1/723 (0.14%)  2/740 (0.27%) 
Aspartate aminotransferase increased †  2/723 (0.28%)  2/740 (0.27%) 
Blood bilirubin increased †  1/723 (0.14%)  0/740 (0.00%) 
Cardiac troponin I increased †  1/723 (0.14%)  1/740 (0.14%) 
Creatinine increased †  4/723 (0.55%)  5/740 (0.68%) 
Ejection fraction decreased †  1/723 (0.14%)  1/740 (0.14%) 
INR increased †  0/723 (0.00%)  2/740 (0.27%) 
Neutrophil count decreased †  0/723 (0.00%)  1/740 (0.14%) 
Weight gain †  1/723 (0.14%)  0/740 (0.00%) 
Weight loss †  0/723 (0.00%)  1/740 (0.14%) 
Metabolism and nutrition disorders     
Acidosis †  1/723 (0.14%)  0/740 (0.00%) 
Anorexia †  0/723 (0.00%)  2/740 (0.27%) 
Dehydration †  1/723 (0.14%)  7/740 (0.95%) 
Hypercalcemia †  1/723 (0.14%)  1/740 (0.14%) 
Hyperglycemia †  1/723 (0.14%)  8/740 (1.08%) 
Hyperkalemia †  1/723 (0.14%)  2/740 (0.27%) 
Hypertriglyceridemia †  1/723 (0.14%)  21/740 (2.84%) 
Hyperuricemia †  1/723 (0.14%)  0/740 (0.00%) 
Hypoalbuminemia †  0/723 (0.00%)  2/740 (0.27%) 
Hypokalemia †  2/723 (0.28%)  1/740 (0.14%) 
Hypomagnesemia †  0/723 (0.00%)  1/740 (0.14%) 
Hyponatremia †  0/723 (0.00%)  3/740 (0.41%) 
Hypophosphatemia †  0/723 (0.00%)  2/740 (0.27%) 
Musculoskeletal and connective tissue disorders     
Arthralgia †  0/723 (0.00%)  1/740 (0.14%) 
Avascular necrosis †  0/723 (0.00%)  1/740 (0.14%) 
Back pain †  1/723 (0.14%)  2/740 (0.27%) 
Flank pain †  2/723 (0.28%)  1/740 (0.14%) 
Generalized muscle weakness †  1/723 (0.14%)  1/740 (0.14%) 
Musculoskeletal and connective tiss disorder - Other †  1/723 (0.14%)  1/740 (0.14%) 
Myalgia †  0/723 (0.00%)  1/740 (0.14%) 
Neck pain †  1/723 (0.14%)  0/740 (0.00%) 
Pain in extremity †  1/723 (0.14%)  1/740 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified - Other †  1/723 (0.14%)  2/740 (0.27%) 
Tumor pain †  1/723 (0.14%)  0/740 (0.00%) 
Nervous system disorders     
Ataxia †  1/723 (0.14%)  0/740 (0.00%) 
Cognitive disturbance †  0/723 (0.00%)  1/740 (0.14%) 
Dizziness †  3/723 (0.41%)  1/740 (0.14%) 
Headache †  1/723 (0.14%)  0/740 (0.00%) 
Intracranial hemorrhage †  1/723 (0.14%)  1/740 (0.14%) 
Memory impairment †  0/723 (0.00%)  1/740 (0.14%) 
Nervous system disorders-Other †  1/723 (0.14%)  1/740 (0.14%) 
Paresthesia †  1/723 (0.14%)  0/740 (0.00%) 
Stroke †  0/723 (0.00%)  1/740 (0.14%) 
Syncope †  3/723 (0.41%)  1/740 (0.14%) 
Transient ischemic attacks †  0/723 (0.00%)  1/740 (0.14%) 
Psychiatric disorders     
Agitation †  1/723 (0.14%)  0/740 (0.00%) 
Confusion †  0/723 (0.00%)  1/740 (0.14%) 
Depression †  1/723 (0.14%)  0/740 (0.00%) 
Suicidal ideation †  1/723 (0.14%)  0/740 (0.00%) 
Renal and urinary disorders     
Acute kidney injury †  4/723 (0.55%)  3/740 (0.41%) 
Chronic kidney disease †  0/723 (0.00%)  2/740 (0.27%) 
Proteinuria †  0/723 (0.00%)  1/740 (0.14%) 
Renal and urinary disorders-Other †  0/723 (0.00%)  2/740 (0.27%) 
Renal calculi †  1/723 (0.14%)  1/740 (0.14%) 
Renal colic †  1/723 (0.14%)  0/740 (0.00%) 
Urinary retention †  0/723 (0.00%)  1/740 (0.14%) 
Urinary tract obstruction †  1/723 (0.14%)  0/740 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough †  0/723 (0.00%)  1/740 (0.14%) 
Dyspnea †  3/723 (0.41%)  10/740 (1.35%) 
Hypoxia †  1/723 (0.14%)  2/740 (0.27%) 
Pleural effusion †  0/723 (0.00%)  2/740 (0.27%) 
Pleuritic pain †  0/723 (0.00%)  1/740 (0.14%) 
Pneumonitis †  0/723 (0.00%)  8/740 (1.08%) 
Resp, thoracic and mediastinal disorders - Other †  1/723 (0.14%)  3/740 (0.41%) 
Respiratory failure †  1/723 (0.14%)  0/740 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus †  0/723 (0.00%)  7/740 (0.95%) 
Rash acneiform †  0/723 (0.00%)  2/740 (0.27%) 
Rash maculo-papular †  0/723 (0.00%)  7/740 (0.95%) 
Skin and subcutaneous tissue disorders - Other †  1/723 (0.14%)  0/740 (0.00%) 
Vascular disorders     
Hematoma †  1/723 (0.14%)  0/740 (0.00%) 
Hypertension †  6/723 (0.83%)  8/740 (1.08%) 
Thromboembolic event †  1/723 (0.14%)  8/740 (1.08%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Everolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   649/723 (89.76%)   716/740 (96.76%) 
Blood and lymphatic system disorders     
Anemia †  151/723 (20.89%)  364/740 (49.19%) 
Gastrointestinal disorders     
Abdominal pain †  111/723 (15.35%)  137/740 (18.51%) 
Constipation †  86/723 (11.89%)  86/740 (11.62%) 
Diarrhea †  145/723 (20.06%)  289/740 (39.05%) 
Dry mouth †  37/723 (5.12%)  55/740 (7.43%) 
Dyspepsia †  46/723 (6.36%)  29/740 (3.92%) 
Mucositis oral †  143/723 (19.78%)  474/740 (64.05%) 
Nausea †  149/723 (20.61%)  208/740 (28.11%) 
Vomiting †  50/723 (6.92%)  90/740 (12.16%) 
General disorders     
Chills †  25/723 (3.46%)  55/740 (7.43%) 
Edema limbs †  77/723 (10.65%)  170/740 (22.97%) 
Fatigue †  366/723 (50.62%)  449/740 (60.68%) 
Fever †  20/723 (2.77%)  61/740 (8.24%) 
Pain †  84/723 (11.62%)  87/740 (11.76%) 
Infections and infestations     
Skin infection †  21/723 (2.90%)  45/740 (6.08%) 
Upper respiratory infection †  44/723 (6.09%)  47/740 (6.35%) 
Investigations     
Alanine aminotransferase increased †  69/723 (9.54%)  143/740 (19.32%) 
Alkaline phosphatase increased †  56/723 (7.75%)  104/740 (14.05%) 
Aspartate aminotransferase increased †  65/723 (8.99%)  159/740 (21.49%) 
Blood bilirubin increased †  40/723 (5.53%)  12/740 (1.62%) 
Cholesterol high †  180/723 (24.90%)  396/740 (53.51%) 
Creatinine increased †  280/723 (38.73%)  323/740 (43.65%) 
Lymphocyte count decreased †  27/723 (3.73%)  93/740 (12.57%) 
Neutrophil count decreased †  21/723 (2.90%)  65/740 (8.78%) 
Platelet count decreased †  41/723 (5.67%)  139/740 (18.78%) 
Weight gain †  82/723 (11.34%)  33/740 (4.46%) 
Weight loss †  17/723 (2.35%)  82/740 (11.08%) 
White blood cell decreased †  41/723 (5.67%)  125/740 (16.89%) 
Metabolism and nutrition disorders     
Anorexia †  48/723 (6.64%)  134/740 (18.11%) 
Hyperglycemia †  268/723 (37.07%)  319/740 (43.11%) 
Hyperkalemia †  68/723 (9.41%)  43/740 (5.81%) 
Hypertriglyceridemia †  295/723 (40.80%)  419/740 (56.62%) 
Hypoalbuminemia †  17/723 (2.35%)  59/740 (7.97%) 
Hypocalcemia †  27/723 (3.73%)  75/740 (10.14%) 
Hypokalemia †  16/723 (2.21%)  49/740 (6.62%) 
Hyponatremia †  52/723 (7.19%)  62/740 (8.38%) 
Musculoskeletal and connective tissue disorders     
Arthralgia †  118/723 (16.32%)  97/740 (13.11%) 
Back pain †  124/723 (17.15%)  97/740 (13.11%) 
Flank pain †  55/723 (7.61%)  39/740 (5.27%) 
Myalgia †  55/723 (7.61%)  74/740 (10.00%) 
Pain in extremity †  90/723 (12.45%)  86/740 (11.62%) 
Nervous system disorders     
Dizziness †  104/723 (14.38%)  112/740 (15.14%) 
Dysgeusia †  48/723 (6.64%)  159/740 (21.49%) 
Headache †  156/723 (21.58%)  214/740 (28.92%) 
Peripheral sensory neuropathy †  53/723 (7.33%)  41/740 (5.54%) 
Psychiatric disorders     
Anxiety †  60/723 (8.30%)  40/740 (5.41%) 
Depression †  42/723 (5.81%)  32/740 (4.32%) 
Insomnia †  84/723 (11.62%)  86/740 (11.62%) 
Renal and urinary disorders     
Urinary frequency †  37/723 (5.12%)  46/740 (6.22%) 
Respiratory, thoracic and mediastinal disorders     
Cough †  162/723 (22.41%)  204/740 (27.57%) 
Dyspnea †  80/723 (11.07%)  156/740 (21.08%) 
Epistaxis †  17/723 (2.35%)  126/740 (17.03%) 
Nasal congestion †  45/723 (6.22%)  73/740 (9.86%) 
Pneumonitis †  4/723 (0.55%)  97/740 (13.11%) 
Sore throat †  22/723 (3.04%)  70/740 (9.46%) 
Skin and subcutaneous tissue disorders     
Dry skin †  77/723 (10.65%)  144/740 (19.46%) 
Erythema multiforme †  12/723 (1.66%)  37/740 (5.00%) 
Pruritus †  80/723 (11.07%)  147/740 (19.86%) 
Rash acneiform †  50/723 (6.92%)  218/740 (29.46%) 
Rash maculo-papular †  70/723 (9.68%)  243/740 (32.84%) 
Skin and subcutaneous tissue disorders - Other †  53/723 (7.33%)  80/740 (10.81%) 
Vascular disorders     
Hypertension †  195/723 (26.97%)  197/740 (26.62%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melissa Plets
Organization: SWOG
Phone: 206.667.2707
EMail: mplets@fredhutch.org
Layout table for additonal information
Responsible Party: SWOG Cancer Research Network
ClinicalTrials.gov Identifier: NCT01120249    
Other Study ID Numbers: S0931
S0931 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
NCI-2011-02028 ( Other Identifier: NCI )
First Submitted: May 7, 2010
First Posted: May 10, 2010
Results First Submitted: November 9, 2023
Results First Posted: March 20, 2024
Last Update Posted: March 20, 2024