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Trial record 14 of 1297 for:    survival | Neuroendocrine Tumors

Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT01229943
Recruitment Status : Active, not recruiting
First Posted : October 28, 2010
Results First Posted : February 11, 2016
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Gastrinoma
Pancreatic Neuroendocrine Tumor G1
Pancreatic Neuroendocrine Tumor G2
Pancreatic Vipoma
Recurrent Pancreatic Neuroendocrine Carcinoma
Interventions Biological: Bevacizumab
Drug: Everolimus
Drug: Octreotide Acetate
Enrollment 150
Recruitment Details From October 2010 to October 2012, 150 participants were recruited and randomized to study treatment.
Pre-assignment Details  
Arm/Group Title Arm I (Octreotide Acetate and Everolimus) Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Hide Arm/Group Description

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >

> Octreotide Acetate: Given IM

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >

> Bevacizumab: Given IV >

> Everolimus: Given PO >

> Octreotide Acetate: Given IM

Period Title: Overall Study
Started 75 75
Completed 57 58
Not Completed 18 17
Arm/Group Title Arm I (Octreotide Acetate and Everolimus) Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) Total
Hide Arm/Group Description

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >

> Octreotide Acetate: Given IM

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >

> Bevacizumab: Given IV >

> Everolimus: Given PO >

> Octreotide Acetate: Given IM

Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 75 participants 75 participants 150 participants
59
(23 to 80)
58
(21 to 86)
58.5
(21 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
35
  46.7%
31
  41.3%
66
  44.0%
Male
40
  53.3%
44
  58.7%
84
  56.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Hispanic or Latino
3
   4.0%
1
   1.3%
4
   2.7%
Not Hispanic or Latino
69
  92.0%
70
  93.3%
139
  92.7%
Unknown or Not Reported
3
   4.0%
4
   5.3%
7
   4.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
American Indian or Alaska Native
0
   0.0%
1
   1.3%
1
   0.7%
Asian
4
   5.3%
2
   2.7%
6
   4.0%
Native Hawaiian or Other Pacific Islander
1
   1.3%
0
   0.0%
1
   0.7%
Black or African American
4
   5.3%
8
  10.7%
12
   8.0%
White
64
  85.3%
61
  81.3%
125
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   2.7%
3
   4.0%
5
   3.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Canada 5 6 11
United States 70 69 139
1.Primary Outcome
Title Progression Free Survival
Hide Description Progression Free Survival (PFS) was defined as the time from study entry until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions (and an absolute increase of at least 0.5 cm) or the appearance of new lesions.
Time Frame From study entry to the date of documented progression or death from any cause, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Octreotide Acetate and Everolimus) Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Hide Arm/Group Description:

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1. > > Everolimus: Given PO >

> Octreotide Acetate: Given IM

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15. >

> Bevacizumab: Given IV >

> Everolimus: Given PO >

> Octreotide Acetate: Given IM

Overall Number of Participants Analyzed 75 75
Median (95% Confidence Interval)
Unit of Measure: months
14.0
(9.1 to 16.9)
16.7
(12.6 to 19.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Octreotide Acetate and Everolimus), Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Comments Based on the log rank test, with 130 patients enrolled over 22 months and followed an additional 24 months, the difference in median PFS between 9 months and 14 months can be detected with approximately 90% power (1-sided, α=0.15).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments Tests were stratified by: prior treatment with cytotoxic chemotherapy (no vs yes), prior use of octreotide (no vs yes), and prior therapy with sunitinib (no vs yes).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.55 to 1.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Response Rate
Hide Description The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Octreotide Acetate and Everolimus) Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Hide Arm/Group Description:

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.

Everolimus: Given PO

Octreotide Acetate: Given IM

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.

Bevacizumab: Given IV

Everolimus: Given PO

Octreotide Acetate: Given IM

Overall Number of Participants Analyzed 75 75
Measure Type: Number
Unit of Measure: percentage of participants
12 31
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.
Time Frame From registration to time of death, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Octreotide Acetate and Everolimus) Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Hide Arm/Group Description:

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.

Everolimus: Given PO

Octreotide Acetate: Given IM

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.

Bevacizumab: Given IV

Everolimus: Given PO

Octreotide Acetate: Given IM

Overall Number of Participants Analyzed 75 75
Median (95% Confidence Interval)
Unit of Measure: months
35.0 [1] 
(29.9 to NA)
36.7 [1] 
(31.8 to NA)
[1]
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
Time Frame [Not Specified]
Adverse Event Reporting Description 147 participants were evaluable for adverse events.
 
Arm/Group Title Arm I (Octreotide Acetate and Everolimus) Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Hide Arm/Group Description

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.

Everolimus: Given PO

Octreotide Acetate: Given IM

Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.

Bevacizumab: Given IV

Everolimus: Given PO

Octreotide Acetate: Given IM

All-Cause Mortality
Arm I (Octreotide Acetate and Everolimus) Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Octreotide Acetate and Everolimus) Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/74 (27.03%)      31/73 (42.47%)    
Blood and lymphatic system disorders     
Anemia  1  4/74 (5.41%)  5 16/73 (21.92%)  25
Blood and lymphatic system disorders - Other  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Cardiac disorders     
Acute coronary syndrome  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Cardiac disorders - Other  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Chest pain - cardiac  1  1/74 (1.35%)  1 2/73 (2.74%)  2
Heart failure  1  0/74 (0.00%)  0 4/73 (5.48%)  5
Left ventricular systolic dysfunction  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Myocardial infarction  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Pericardial effusion  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Sinus bradycardia  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Eye disorders     
Blurred vision  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Eye pain  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Watering eyes  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Abdominal pain  1  4/74 (5.41%)  5 5/73 (6.85%)  5
Ascites  1  0/74 (0.00%)  0 4/73 (5.48%)  5
Bloating  1  1/74 (1.35%)  1 3/73 (4.11%)  3
Constipation  1  1/74 (1.35%)  1 4/73 (5.48%)  4
Diarrhea  1  5/74 (6.76%)  5 14/73 (19.18%)  18
Dry mouth  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Duodenal obstruction  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Duodenal ulcer  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Dyspepsia  1  2/74 (2.70%)  2 3/73 (4.11%)  3
Gastroesophageal reflux disease  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Gastrointestinal disorders - Other  1  0/74 (0.00%)  0 2/73 (2.74%)  3
Gastrointestinal pain  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Gastroparesis  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Hemorrhoids  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Mucositis oral  1  4/74 (5.41%)  4 3/73 (4.11%)  4
Nausea  1  8/74 (10.81%)  8 13/73 (17.81%)  16
Obstruction gastric  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Pancreatitis  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Upper gastrointestinal hemorrhage  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Vomiting  1  1/74 (1.35%)  1 10/73 (13.70%)  12
General disorders     
Chills  1  0/74 (0.00%)  0 2/73 (2.74%)  4
Edema limbs  1  2/74 (2.70%)  2 11/73 (15.07%)  15
Edema trunk  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Fatigue  1  15/74 (20.27%)  18 21/73 (28.77%)  31
Fever  1  2/74 (2.70%)  2 5/73 (6.85%)  7
Malaise  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Non-cardiac chest pain  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Pain  1  1/74 (1.35%)  1 5/73 (6.85%)  5
Hepatobiliary disorders     
Gallbladder obstruction  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Hepatic failure  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Hepatic pain  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Hepatobiliary disorders - Other  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Immune system disorders     
Allergic reaction  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Infections and infestations     
Abdominal infection  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Hepatic infection  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Infective myositis  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Lung infection  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Nail infection  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Sepsis  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Skin infection  1  2/74 (2.70%)  3 2/73 (2.74%)  2
Upper respiratory infection  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Urinary tract infection  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Wound infection  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications - Other  1  1/74 (1.35%)  1 1/73 (1.37%)  1
Wound complication  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Investigations     
Activated partial thromboplastin time prolonged  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Alanine aminotransferase increased  1  7/74 (9.46%)  8 7/73 (9.59%)  9
Alkaline phosphatase increased  1  2/74 (2.70%)  3 9/73 (12.33%)  13
Aspartate aminotransferase increased  1  8/74 (10.81%)  9 12/73 (16.44%)  20
Blood bilirubin increased  1  1/74 (1.35%)  2 5/73 (6.85%)  8
CPK increased  1  1/74 (1.35%)  2 0/73 (0.00%)  0
Cholesterol high  1  4/74 (5.41%)  4 6/73 (8.22%)  8
Creatinine increased  1  3/74 (4.05%)  3 9/73 (12.33%)  13
Ejection fraction decreased  1  0/74 (0.00%)  0 1/73 (1.37%)  1
GGT increased  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Hemoglobin increased  1  0/74 (0.00%)  0 1/73 (1.37%)  1
INR increased  1  0/74 (0.00%)  0 4/73 (5.48%)  5
Lipase increased  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Lymphocyte count decreased  1  3/74 (4.05%)  4 2/73 (2.74%)  4
Neutrophil count decreased  1  4/74 (5.41%)  5 2/73 (2.74%)  2
Platelet count decreased  1  4/74 (5.41%)  7 9/73 (12.33%)  16
Serum amylase increased  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Weight gain  1  0/74 (0.00%)  0 3/73 (4.11%)  4
Weight loss  1  0/74 (0.00%)  0 12/73 (16.44%)  18
White blood cell decreased  1  0/74 (0.00%)  0 5/73 (6.85%)  6
Metabolism and nutrition disorders     
Anorexia  1  5/74 (6.76%)  6 11/73 (15.07%)  13
Dehydration  1  1/74 (1.35%)  1 6/73 (8.22%)  8
Hyperglycemia  1  10/74 (13.51%)  12 21/73 (28.77%)  35
Hyperkalemia  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Hypernatremia  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Hypertriglyceridemia  1  4/74 (5.41%)  5 5/73 (6.85%)  6
Hyperuricemia  1  0/74 (0.00%)  0 4/73 (5.48%)  5
Hypoalbuminemia  1  3/74 (4.05%)  4 11/73 (15.07%)  15
Hypocalcemia  1  1/74 (1.35%)  1 8/73 (10.96%)  14
Hypoglycemia  1  1/74 (1.35%)  1 4/73 (5.48%)  4
Hypokalemia  1  2/74 (2.70%)  2 5/73 (6.85%)  7
Hypomagnesemia  1  1/74 (1.35%)  1 7/73 (9.59%)  8
Hyponatremia  1  2/74 (2.70%)  2 11/73 (15.07%)  13
Hypophosphatemia  1  0/74 (0.00%)  0 4/73 (5.48%)  5
Serum glucose decreased  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/74 (4.05%)  4 2/73 (2.74%)  6
Back pain  1  1/74 (1.35%)  1 2/73 (2.74%)  2
Bone pain  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Chest wall pain  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Flank pain  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Generalized muscle weakness  1  1/74 (1.35%)  1 5/73 (6.85%)  5
Musculoskeletal and connective tissue disorder - Other  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Myalgia  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Pain in extremity  1  1/74 (1.35%)  2 2/73 (2.74%)  3
Nervous system disorders     
Amnesia  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Concentration impairment  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Dizziness  1  1/74 (1.35%)  1 3/73 (4.11%)  3
Dysesthesia  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Dysgeusia  1  1/74 (1.35%)  1 5/73 (6.85%)  5
Encephalopathy  1  1/74 (1.35%)  1 2/73 (2.74%)  4
Headache  1  4/74 (5.41%)  4 5/73 (6.85%)  5
Intracranial hemorrhage  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Lethargy  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Neuralgia  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Paresthesia  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Peripheral sensory neuropathy  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Presyncope  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Syncope  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Psychiatric disorders     
Anxiety  1  2/74 (2.70%)  2 3/73 (4.11%)  4
Confusion  1  0/74 (0.00%)  0 3/73 (4.11%)  3
Depression  1  1/74 (1.35%)  1 1/73 (1.37%)  1
Insomnia  1  2/74 (2.70%)  2 3/73 (4.11%)  3
Renal and urinary disorders     
Acute kidney injury  1  0/74 (0.00%)  0 5/73 (6.85%)  6
Chronic kidney disease  1  0/74 (0.00%)  0 3/73 (4.11%)  4
Hemoglobinuria  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Proteinuria  1  1/74 (1.35%)  2 13/73 (17.81%)  17
Urinary frequency  1  1/74 (1.35%)  2 1/73 (1.37%)  3
Reproductive system and breast disorders     
Genital edema  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Menorrhagia  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchopulmonary hemorrhage  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Cough  1  1/74 (1.35%)  2 3/73 (4.11%)  3
Dyspnea  1  3/74 (4.05%)  4 7/73 (9.59%)  8
Epistaxis  1  1/74 (1.35%)  1 7/73 (9.59%)  11
Hiccups  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Hoarseness  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Hypoxia  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Pharyngolaryngeal pain  1  1/74 (1.35%)  2 0/73 (0.00%)  0
Pleural effusion  1  0/74 (0.00%)  0 5/73 (6.85%)  5
Pneumonitis  1  4/74 (5.41%)  5 0/73 (0.00%)  0
Productive cough  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Respiratory, thoracic and mediastinal disorders - Other  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Sore throat  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Voice alteration  1  1/74 (1.35%)  2 0/73 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  1/74 (1.35%)  2 2/73 (2.74%)  2
Dry skin  1  2/74 (2.70%)  3 1/73 (1.37%)  1
Hyperhidrosis  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Pruritus  1  3/74 (4.05%)  5 2/73 (2.74%)  2
Rash acneiform  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Rash maculo-papular  1  4/74 (5.41%)  4 6/73 (8.22%)  7
Skin and subcutaneous tissue disorders - Other  1  1/74 (1.35%)  2 2/73 (2.74%)  2
Skin hyperpigmentation  1  1/74 (1.35%)  2 0/73 (0.00%)  0
Skin ulceration  1  1/74 (1.35%)  1 2/73 (2.74%)  3
Vascular disorders     
Hypertension  1  6/74 (8.11%)  7 18/73 (24.66%)  26
Hypotension  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Lymphedema  1  1/74 (1.35%)  2 0/73 (0.00%)  0
Thromboembolic event  1  0/74 (0.00%)  0 3/73 (4.11%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Octreotide Acetate and Everolimus) Arm II (Octreotide Acetate, Everolimus, and Bevacizumab)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   73/74 (98.65%)      72/73 (98.63%)    
Blood and lymphatic system disorders     
Anemia  1  29/74 (39.19%)  226 40/73 (54.79%)  332
Blood and lymphatic system disorders - Other  1  1/74 (1.35%)  2 4/73 (5.48%)  6
Hemolysis  1  0/74 (0.00%)  0 1/73 (1.37%)  3
Hemolytic uremic syndrome  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Leukocytosis  1  1/74 (1.35%)  1 1/73 (1.37%)  2
Lymph node pain  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Thrombotic thrombocytopenic purpura  1  1/74 (1.35%)  7 0/73 (0.00%)  0
Cardiac disorders     
Cardiac arrest  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Cardiac disorders - Other  1  0/74 (0.00%)  0 1/73 (1.37%)  4
Chest pain - cardiac  1  2/74 (2.70%)  7 1/73 (1.37%)  3
Heart failure  1  0/74 (0.00%)  0 2/73 (2.74%)  12
Myocardial infarction  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Palpitations  1  3/74 (4.05%)  3 0/73 (0.00%)  0
Pericardial effusion  1  1/74 (1.35%)  1 4/73 (5.48%)  9
Sinus tachycardia  1  0/74 (0.00%)  0 2/73 (2.74%)  8
Ear and labyrinth disorders     
Ear and labyrinth disorders - Other  1  0/74 (0.00%)  0 2/73 (2.74%)  3
Ear pain  1  1/74 (1.35%)  1 2/73 (2.74%)  2
Hearing impaired  1  1/74 (1.35%)  21 2/73 (2.74%)  24
Middle ear inflammation  1  0/74 (0.00%)  0 1/73 (1.37%)  5
Tinnitus  1  2/74 (2.70%)  37 3/73 (4.11%)  9
Vertigo  1  1/74 (1.35%)  1 1/73 (1.37%)  1
Endocrine disorders     
Endocrine disorders - Other  1  0/74 (0.00%)  0 1/73 (1.37%)  22
Eye disorders     
Blurred vision  1  4/74 (5.41%)  36 6/73 (8.22%)  13
Cataract  1  0/74 (0.00%)  0 1/73 (1.37%)  4
Conjunctivitis  1  2/74 (2.70%)  5 3/73 (4.11%)  5
Dry eye  1  2/74 (2.70%)  37 4/73 (5.48%)  30
Extraocular muscle paresis  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Eye disorders - Other  1  3/74 (4.05%)  35 3/73 (4.11%)  9
Eye pain  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Floaters  1  1/74 (1.35%)  19 0/73 (0.00%)  0
Retinal detachment  1  0/74 (0.00%)  0 1/73 (1.37%)  4
Watering eyes  1  1/74 (1.35%)  13 0/73 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  3/74 (4.05%)  12 3/73 (4.11%)  3
Abdominal pain  1  26/74 (35.14%)  115 25/73 (34.25%)  62
Anal fistula  1  0/74 (0.00%)  0 1/73 (1.37%)  5
Anal hemorrhage  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Anal mucositis  1  1/74 (1.35%)  1 1/73 (1.37%)  1
Anal pain  1  1/74 (1.35%)  2 3/73 (4.11%)  25
Ascites  1  2/74 (2.70%)  2 2/73 (2.74%)  2
Bloating  1  4/74 (5.41%)  13 10/73 (13.70%)  27
Constipation  1  15/74 (20.27%)  54 17/73 (23.29%)  67
Dental caries  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Diarrhea  1  48/74 (64.86%)  244 50/73 (68.49%)  324
Dry mouth  1  6/74 (8.11%)  67 5/73 (6.85%)  9
Dyspepsia  1  9/74 (12.16%)  65 7/73 (9.59%)  37
Dysphagia  1  2/74 (2.70%)  2 1/73 (1.37%)  1
Esophageal hemorrhage  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Esophageal stenosis  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Fecal incontinence  1  1/74 (1.35%)  8 2/73 (2.74%)  3
Flatulence  1  5/74 (6.76%)  57 11/73 (15.07%)  37
Gastric fistula  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Gastritis  1  2/74 (2.70%)  3 1/73 (1.37%)  1
Gastroesophageal reflux disease  1  4/74 (5.41%)  5 5/73 (6.85%)  31
Gastrointestinal disorders - Other  1  5/74 (6.76%)  12 4/73 (5.48%)  14
Gastrointestinal pain  1  1/74 (1.35%)  3 1/73 (1.37%)  3
Gingival pain  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Hemorrhoidal hemorrhage  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Hemorrhoids  1  1/74 (1.35%)  2 9/73 (12.33%)  49
Ileal fistula  1  0/74 (0.00%)  0 1/73 (1.37%)  4
Lip pain  1  1/74 (1.35%)  1 1/73 (1.37%)  2
Lower gastrointestinal hemorrhage  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Mucositis oral  1  48/74 (64.86%)  280 43/73 (58.90%)  173
Nausea  1  36/74 (48.65%)  158 38/73 (52.05%)  154
Oral hemorrhage  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Oral pain  1  2/74 (2.70%)  10 3/73 (4.11%)  11
Pancreatitis  1  0/74 (0.00%)  0 2/73 (2.74%)  11
Periodontal disease  1  0/74 (0.00%)  0 4/73 (5.48%)  7
Rectal hemorrhage  1  0/74 (0.00%)  0 2/73 (2.74%)  2
Rectal pain  1  0/74 (0.00%)  0 1/73 (1.37%)  3
Toothache  1  2/74 (2.70%)  3 1/73 (1.37%)  2
Upper gastrointestinal hemorrhage  1  0/74 (0.00%)  0 2/73 (2.74%)  3
Vomiting  1  14/74 (18.92%)  32 22/73 (30.14%)  61
General disorders     
Chills  1  6/74 (8.11%)  30 13/73 (17.81%)  71
Dysmenorrhea  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Edema face  1  2/74 (2.70%)  2 1/73 (1.37%)  1
Edema limbs  1  17/74 (22.97%)  83 25/73 (34.25%)  175
Edema trunk  1  1/74 (1.35%)  1 1/73 (1.37%)  3
Facial pain  1  1/74 (1.35%)  2 1/73 (1.37%)  2
Fatigue  1  60/74 (81.08%)  521 63/73 (86.30%)  521
Fever  1  9/74 (12.16%)  14 7/73 (9.59%)  12
Flu like symptoms  1  4/74 (5.41%)  15 5/73 (6.85%)  11
Gait disturbance  1  2/74 (2.70%)  6 0/73 (0.00%)  0
General disorders and administration site conditions - Other  1  3/74 (4.05%)  3 3/73 (4.11%)  3
Localized edema  1  2/74 (2.70%)  2 2/73 (2.74%)  5
Malaise  1  0/74 (0.00%)  0 3/73 (4.11%)  24
Neck edema  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Non-cardiac chest pain  1  3/74 (4.05%)  3 5/73 (6.85%)  7
Pain  1  12/74 (16.22%)  85 16/73 (21.92%)  59
Hepatobiliary disorders     
Hepatic failure  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Immune system disorders     
Allergic reaction  1  0/74 (0.00%)  0 1/73 (1.37%)  5
Autoimmune disorder  1  0/74 (0.00%)  0 1/73 (1.37%)  16
Immune system disorders - Other  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Infections and infestations     
Bladder infection  1  1/74 (1.35%)  1 1/73 (1.37%)  1
Eye infection  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Gum infection  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Hepatic infection  1  1/74 (1.35%)  2 0/73 (0.00%)  0
Infections and infestations - Other  1  2/74 (2.70%)  2 5/73 (6.85%)  11
Lip infection  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Lung infection  1  1/74 (1.35%)  1 3/73 (4.11%)  3
Otitis media  1  1/74 (1.35%)  1 1/73 (1.37%)  1
Papulopustular rash  1  1/74 (1.35%)  2 0/73 (0.00%)  0
Paronychia  1  0/74 (0.00%)  0 1/73 (1.37%)  22
Pharyngitis  1  1/74 (1.35%)  1 1/73 (1.37%)  1
Prostate infection  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Salivary gland infection  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Sepsis  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Sinusitis  1  4/74 (5.41%)  6 4/73 (5.48%)  10
Skin infection  1  5/74 (6.76%)  8 4/73 (5.48%)  7
Tooth infection  1  3/74 (4.05%)  3 4/73 (5.48%)  4
Upper respiratory infection  1  7/74 (9.46%)  14 6/73 (8.22%)  6
Urinary tract infection  1  3/74 (4.05%)  3 5/73 (6.85%)  17
Vulval infection  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Wound infection  1  0/74 (0.00%)  0 1/73 (1.37%)  7
Injury, poisoning and procedural complications     
Bruising  1  2/74 (2.70%)  7 3/73 (4.11%)  5
Burn  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Fall  1  1/74 (1.35%)  2 1/73 (1.37%)  1
Fracture  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Injury, poisoning and procedural complications - Other  1  0/74 (0.00%)  0 3/73 (4.11%)  25
Intraoperative skin injury  1  0/74 (0.00%)  0 1/73 (1.37%)  3
Wound complication  1  0/74 (0.00%)  0 1/73 (1.37%)  10
Wound dehiscence  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Investigations     
Alanine aminotransferase increased  1  28/74 (37.84%)  158 28/73 (38.36%)  172
Alkaline phosphatase increased  1  22/74 (29.73%)  126 32/73 (43.84%)  275
Aspartate aminotransferase increased  1  38/74 (51.35%)  182 40/73 (54.79%)  317
Blood bilirubin increased  1  3/74 (4.05%)  10 9/73 (12.33%)  33
CD4 lymphocytes decreased  1  0/74 (0.00%)  0 5/73 (6.85%)  11
CPK increased  1  1/74 (1.35%)  2 0/73 (0.00%)  0
Cardiac troponin I increased  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Cholesterol high  1  29/74 (39.19%)  178 35/73 (47.95%)  216
Creatinine increased  1  9/74 (12.16%)  35 18/73 (24.66%)  103
Hemoglobin increased  1  1/74 (1.35%)  3 1/73 (1.37%)  3
INR increased  1  1/74 (1.35%)  1 3/73 (4.11%)  17
Investigations - Other  1  2/74 (2.70%)  9 0/73 (0.00%)  0
Lymphocyte count decreased  1  11/74 (14.86%)  89 8/73 (10.96%)  33
Lymphocyte count increased  1  4/74 (5.41%)  12 1/73 (1.37%)  2
Neutrophil count decreased  1  26/74 (35.14%)  74 17/73 (23.29%)  43
Pancreatic enzymes decreased  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Platelet count decreased  1  29/74 (39.19%)  202 34/73 (46.58%)  198
Weight gain  1  0/74 (0.00%)  0 5/73 (6.85%)  17
Weight loss  1  17/74 (22.97%)  73 27/73 (36.99%)  132
White blood cell decreased  1  17/74 (22.97%)  99 14/73 (19.18%)  76
Metabolism and nutrition disorders     
Acidosis  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Anorexia  1  21/74 (28.38%)  104 27/73 (36.99%)  104
Dehydration  1  2/74 (2.70%)  2 2/73 (2.74%)  5
Glucose intolerance  1  1/74 (1.35%)  2 0/73 (0.00%)  0
Hypercalcemia  1  5/74 (6.76%)  25 2/73 (2.74%)  11
Hyperglycemia  1  54/74 (72.97%)  485 56/73 (76.71%)  479
Hyperkalemia  1  5/74 (6.76%)  11 8/73 (10.96%)  16
Hypermagnesemia  1  2/74 (2.70%)  6 2/73 (2.74%)  2
Hypernatremia  1  0/74 (0.00%)  0 5/73 (6.85%)  8
Hypertriglyceridemia  1  36/74 (48.65%)  161 37/73 (50.68%)  249
Hyperuricemia  1  2/74 (2.70%)  24 8/73 (10.96%)  28
Hypoalbuminemia  1  12/74 (16.22%)  44 23/73 (31.51%)  116
Hypocalcemia  1  13/74 (17.57%)  46 25/73 (34.25%)  89
Hypoglycemia  1  11/74 (14.86%)  22 6/73 (8.22%)  9
Hypokalemia  1  9/74 (12.16%)  30 16/73 (21.92%)  53
Hypomagnesemia  1  11/74 (14.86%)  81 14/73 (19.18%)  77
Hyponatremia  1  10/74 (13.51%)  42 18/73 (24.66%)  76
Hypophosphatemia  1  12/74 (16.22%)  38 21/73 (28.77%)  58
Metabolism and nutrition disorders - Other  1  4/74 (5.41%)  10 2/73 (2.74%)  8
Musculoskeletal and connective tissue disorders     
Arthralgia  1  8/74 (10.81%)  59 11/73 (15.07%)  111
Arthritis  1  2/74 (2.70%)  11 2/73 (2.74%)  11
Back pain  1  18/74 (24.32%)  78 8/73 (10.96%)  39
Bone pain  1  3/74 (4.05%)  5 1/73 (1.37%)  6
Chest wall pain  1  1/74 (1.35%)  1 1/73 (1.37%)  1
Flank pain  1  1/74 (1.35%)  1 3/73 (4.11%)  7
Generalized muscle weakness  1  7/74 (9.46%)  31 10/73 (13.70%)  58
Joint effusion  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Joint range of motion decreased  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Musculoskeletal and connective tissue disorder - Other  1  5/74 (6.76%)  52 5/73 (6.85%)  27
Myalgia  1  8/74 (10.81%)  88 12/73 (16.44%)  45
Neck pain  1  0/74 (0.00%)  0 3/73 (4.11%)  19
Pain in extremity  1  8/74 (10.81%)  49 11/73 (15.07%)  33
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Treatment related secondary malignancy  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Tumor pain  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Nervous system disorders     
Cognitive disturbance  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Concentration impairment  1  2/74 (2.70%)  23 1/73 (1.37%)  1
Dizziness  1  11/74 (14.86%)  52 13/73 (17.81%)  24
Dysesthesia  1  0/74 (0.00%)  0 1/73 (1.37%)  9
Dysgeusia  1  9/74 (12.16%)  39 13/73 (17.81%)  75
Encephalopathy  1  1/74 (1.35%)  1 1/73 (1.37%)  1
Headache  1  23/74 (31.08%)  120 32/73 (43.84%)  150
Memory impairment  1  1/74 (1.35%)  24 0/73 (0.00%)  0
Nervous system disorders - Other  1  3/74 (4.05%)  51 1/73 (1.37%)  1
Neuralgia  1  0/74 (0.00%)  0 2/73 (2.74%)  5
Paresthesia  1  0/74 (0.00%)  0 3/73 (4.11%)  3
Peripheral motor neuropathy  1  2/74 (2.70%)  3 0/73 (0.00%)  0
Peripheral sensory neuropathy  1  7/74 (9.46%)  35 15/73 (20.55%)  42
Sinus pain  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Syncope  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Tremor  1  0/74 (0.00%)  0 2/73 (2.74%)  10
Psychiatric disorders     
Agitation  1  1/74 (1.35%)  3 0/73 (0.00%)  0
Anxiety  1  9/74 (12.16%)  47 7/73 (9.59%)  66
Confusion  1  0/74 (0.00%)  0 4/73 (5.48%)  4
Delusions  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Depression  1  7/74 (9.46%)  88 8/73 (10.96%)  74
Insomnia  1  17/74 (22.97%)  148 18/73 (24.66%)  146
Libido decreased  1  1/74 (1.35%)  11 0/73 (0.00%)  0
Libido increased  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Mania  1  0/74 (0.00%)  0 1/73 (1.37%)  5
Personality change  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Psychiatric disorders - Other  1  1/74 (1.35%)  2 1/73 (1.37%)  3
Renal and urinary disorders     
Acute kidney injury  1  1/74 (1.35%)  1 1/73 (1.37%)  1
Bladder spasm  1  1/74 (1.35%)  2 0/73 (0.00%)  0
Chronic kidney disease  1  1/74 (1.35%)  2 8/73 (10.96%)  45
Cystitis noninfective  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Hematuria  1  4/74 (5.41%)  5 5/73 (6.85%)  16
Hemoglobinuria  1  0/74 (0.00%)  0 3/73 (4.11%)  41
Proteinuria  1  12/74 (16.22%)  42 46/73 (63.01%)  393
Renal and urinary disorders - Other  1  1/74 (1.35%)  1 4/73 (5.48%)  7
Renal calculi  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Urinary frequency  1  2/74 (2.70%)  11 4/73 (5.48%)  44
Urinary retention  1  0/74 (0.00%)  0 2/73 (2.74%)  23
Urinary tract pain  1  2/74 (2.70%)  3 1/73 (1.37%)  2
Urinary urgency  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Reproductive system and breast disorders     
Erectile dysfunction  1  0/74 (0.00%)  0 1/73 (1.37%)  22
Genital edema  1  1/74 (1.35%)  2 1/73 (1.37%)  5
Irregular menstruation  1  2/74 (2.70%)  2 3/73 (4.11%)  21
Menorrhagia  1  2/74 (2.70%)  2 0/73 (0.00%)  0
Pelvic pain  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Penile pain  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Prostatic obstruction  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Reproductive system and breast disorders - Other  1  0/74 (0.00%)  0 1/73 (1.37%)  22
Vaginal discharge  1  1/74 (1.35%)  2 1/73 (1.37%)  1
Vaginal dryness  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Vaginal inflammation  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  0/74 (0.00%)  0 3/73 (4.11%)  9
Bronchial stricture  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Bronchopulmonary hemorrhage  1  0/74 (0.00%)  0 1/73 (1.37%)  2
Cough  1  24/74 (32.43%)  60 18/73 (24.66%)  47
Dyspnea  1  11/74 (14.86%)  30 12/73 (16.44%)  25
Epistaxis  1  11/74 (14.86%)  37 46/73 (63.01%)  242
Hiccups  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Hoarseness  1  0/74 (0.00%)  0 5/73 (6.85%)  28
Laryngeal hemorrhage  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Laryngeal inflammation  1  0/74 (0.00%)  0 2/73 (2.74%)  3
Nasal congestion  1  2/74 (2.70%)  18 8/73 (10.96%)  36
Pharyngolaryngeal pain  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Pleural effusion  1  3/74 (4.05%)  3 3/73 (4.11%)  7
Pleuritic pain  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Pneumonitis  1  6/74 (8.11%)  6 9/73 (12.33%)  22
Pneumothorax  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Postnasal drip  1  2/74 (2.70%)  3 5/73 (6.85%)  60
Productive cough  1  3/74 (4.05%)  6 4/73 (5.48%)  8
Pulmonary fibrosis  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Pulmonary hypertension  1  1/74 (1.35%)  1 0/73 (0.00%)  0
Respiratory failure  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Respiratory, thoracic and mediastinal disorders - Other  1  2/74 (2.70%)  9 4/73 (5.48%)  39
Sinus disorder  1  1/74 (1.35%)  3 0/73 (0.00%)  0
Sleep apnea  1  0/74 (0.00%)  0 1/73 (1.37%)  22
Sore throat  1  3/74 (4.05%)  10 10/73 (13.70%)  11
Voice alteration  1  0/74 (0.00%)  0 3/73 (4.11%)  15
Skin and subcutaneous tissue disorders     
Alopecia  1  7/74 (9.46%)  25 4/73 (5.48%)  20
Bullous dermatitis  1  1/74 (1.35%)  16 0/73 (0.00%)  0
Dry skin  1  13/74 (17.57%)  60 16/73 (21.92%)  128
Erythema multiforme  1  1/74 (1.35%)  1 1/73 (1.37%)  2
Hyperhidrosis  1  2/74 (2.70%)  22 1/73 (1.37%)  1
Nail discoloration  1  1/74 (1.35%)  1 1/73 (1.37%)  2
Nail loss  1  3/74 (4.05%)  35 1/73 (1.37%)  1
Nail ridging  1  1/74 (1.35%)  2 3/73 (4.11%)  7
Pain of skin  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Palmar-plantar erythrodysesthesia syndrome  1  2/74 (2.70%)  15 2/73 (2.74%)  4
Periorbital edema  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Pruritus  1  13/74 (17.57%)  76 11/73 (15.07%)  70
Rash acneiform  1  4/74 (5.41%)  32 11/73 (15.07%)  87
Rash maculo-papular  1  24/74 (32.43%)  66 38/73 (52.05%)  151
Scalp pain  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Skin and subcutaneous tissue disorders - Other  1  9/74 (12.16%)  67 11/73 (15.07%)  131
Skin hyperpigmentation  1  1/74 (1.35%)  5 1/73 (1.37%)  6
Skin hypopigmentation  1  0/74 (0.00%)  0 2/73 (2.74%)  7
Skin ulceration  1  4/74 (5.41%)  8 0/73 (0.00%)  0
Surgical and medical procedures     
Surgical and medical procedures - Other  1  0/74 (0.00%)  0 1/73 (1.37%)  1
Vascular disorders     
Flushing  1  2/74 (2.70%)  3 1/73 (1.37%)  8
Hematoma  1  2/74 (2.70%)  2 0/73 (0.00%)  0
Hot flashes  1  3/74 (4.05%)  3 5/73 (6.85%)  6
Hypertension  1  38/74 (51.35%)  226 59/73 (80.82%)  542
Hypotension  1  1/74 (1.35%)  1 4/73 (5.48%)  5
Lymphedema  1  1/74 (1.35%)  3 0/73 (0.00%)  0
Thromboembolic event  1  2/74 (2.70%)  9 6/73 (8.22%)  13
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
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
Name/Title: Matthew Kulke, MD, MMSc
Organization: Dana-Farber Cancer Institute
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01229943     History of Changes
Other Study ID Numbers: NCI-2011-02609
NCI-2011-02609 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000687459
CALGB-80701
CALGB-80701 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-80701 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 2010
First Posted: October 28, 2010
Results First Submitted: January 13, 2016
Results First Posted: February 11, 2016
Last Update Posted: July 15, 2019