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Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100 (COMET-1)

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ClinicalTrials.gov Identifier: NCT01605227
Recruitment Status : Completed
First Posted : May 24, 2012
Results First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Exelixis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Prostate Cancer
Castration Resistant Prostate Cancer
Pain
Prostatic Neoplasms
Interventions Drug: cabozantinib
Drug: prednisone
Enrollment 1028
Recruitment Details First patient enrolled: 02 July 2012 (first subject randomized), Data cut off date: 07 July 2014
Pre-assignment Details  
Arm/Group Title Cabozantinib Prednisone
Hide Arm/Group Description

Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.

Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.

Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.

Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.

Period Title: Overall Study
Started [1] 682 346
Completed [2] 61 17
Not Completed 621 329
Reason Not Completed
Did not receive study treatment             2             3
Adverse Event             228             42
Progressive Disease             132             128
Clinical Deterioration             227             133
Lost to Follow-up             1             0
Protocol Violation             1             0
Physician Decision             9             7
Withdrawal by Subject             18             14
Sponsor Decision             2             0
Started New Therapy             1             0
Subject Decision             0             1
Dose Held >6 weeks             0             1
[1]
Randomized
[2]
Subjects still on study treatment at data cut-off date
Arm/Group Title Cabozantinib Prednisone Total
Hide Arm/Group Description

Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.

Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.

Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.

Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.

Total of all reporting groups
Overall Number of Baseline Participants 682 346 1028
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
165
  24.2%
97
  28.0%
262
  25.5%
>=65 years
517
  75.8%
249
  72.0%
766
  74.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
682
 100.0%
346
 100.0%
1028
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
American Indian or Alaska Native
0
   0.0%
1
   0.3%
1
   0.1%
Asian
2
   0.3%
0
   0.0%
2
   0.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
14
   2.1%
6
   1.7%
20
   1.9%
White
520
  76.2%
265
  76.6%
785
  76.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
146
  21.4%
74
  21.4%
220
  21.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
North America
119
  17.4%
63
  18.2%
182
  17.7%
Europe
528
  77.4%
256
  74.0%
784
  76.3%
Australia
35
   5.1%
27
   7.8%
62
   6.0%
Prior cabazitaxel (per CRF)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
Yes
261
  38.3%
132
  38.2%
393
  38.2%
No
421
  61.7%
214
  61.8%
635
  61.8%
Brief Pain Inventory (BPI) Item 3 (per CRF)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
<4
389
  57.0%
196
  56.6%
585
  56.9%
≥4
284
  41.6%
148
  42.8%
432
  42.0%
Missing
9
   1.3%
2
   0.6%
11
   1.1%
[1]
Measure Description: Pain will be assessed using the BPI Items #3 (worst pain over the last 24 hours by recall).
ECOG Performance Status (per CRF)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
0/1 (asymptomatic or symptomatic but ambulatory) 605 303 908
2 (ambulatory but can't carry out work activities) 76 43 119
Missing 1 0 1
Opioid narcotic use within 24 hours (per solicited oploid CRF)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
454
  66.6%
228
  65.9%
682
  66.3%
Concomitant prednisone/prednisolone at randomization  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
289
  42.4%
142
  41.0%
431
  41.9%
Time from diagnosis to study entry  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 682 participants 346 participants 1028 participants
6.68
(0.09 to 26.6)
6.98
(0.04 to 22.2)
6.83
(0.04 to 26.6)
Bone scan lesion area  
Median (Full Range)
Unit of measure:  Mm^2
Number Analyzed 682 participants 346 participants 1028 participants
45,635.5
(0 to 388,052)
41,746.0
(0 to 283,304)
44,782.0
(0 to 388,052)
Extent of metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
None 0 0 0
Bone 681 346 1027
Lymph node 313 140 453
Visceral 133 58 191
Liver 91 35 126
Lung 69 29 98
Other soft tissue 39 23 62
No. of prior anticancer agents   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
2 57 31 88
≥3 625 315 940
[1]
Measure Description: Excluding agents to maintain castration status
Baseline LDH  
Median (Full Range)
Unit of measure:  U/L
Number Analyzed 682 participants 346 participants 1028 participants
230
(59 to 6004)
230
(87 to 3062)
230
(59 to 6004)
Baseline PSA  
Median (Full Range)
Unit of measure:  μg/L
Number Analyzed 682 participants 346 participants 1028 participants
192
(0.02 to 10030)
195
(0.54 to 10963)
192
(0 to 10963)
Baseline serum testosterone (<50 ng/dL)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 682 participants 346 participants 1028 participants
677
  99.3%
345
  99.7%
1022
  99.4%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred.
Time Frame OS was measured from the time of randomization until 614 events, approximately 24 months after study start
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to Treat (ITT) population was used and included 1028 randomized subjects (682 cabozantinib, 346 prednisone).
Arm/Group Title Cabozantinib Prednisone
Hide Arm/Group Description:

Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.

Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.

Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.

Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.

Overall Number of Participants Analyzed 682 346
Median (95% Confidence Interval)
Unit of Measure: months
11.0
(10.09 to 11.63)
9.8
(9.00 to 11.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cabozantinib, Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.213
Comments [Not Specified]
Method Log Rank
Comments The Log-Rank test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.76 to 1.06
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Bone Scan Response (BSR)
Hide Description BSR is defined as >=30% reduction in the bone scan lesion area (BSLA) compared with baseline. Confirmation of bone scan was not required for response or progression. Bone scans were evaluated by an independent radiology facility (IRF) for response.
Time Frame BSR was measured at the end of Week 12 as determined by the IRF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the ITT population (682 cabozantinib, 346 prednisone) for Bone Scan Response (BSR) at Week 12.
Arm/Group Title Cabozantinib Prednisone
Hide Arm/Group Description:

Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.

Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.

Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.

Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.

Overall Number of Participants Analyzed 682 346
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42
(38 to 46)
3
(1 to 5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cabozantinib, Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments The Cochran-Mantel-Haenszel (CMH) Test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.
3.Other Pre-specified Outcome
Title Progression-free Survival (PFS)
Hide Description The exploratory analysis of PFS is the time from randomization to date of first documented radiographic progression (bone and/or soft tissue) according to the investigator's assessment or death. PFS was defined per mRECIST 1.1 and included evaluation of measurable, nonmeasurable, target and nontarget lesions. A Kaplan-Meier analysis was performed to estimate the median duration.
Time Frame Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to Treat (ITT) population was used and include 1028 randomized subjects (682 cabozantinib, 346 prednisone) with a data cut off date of 07 July 2014.
Arm/Group Title Cabozantinib Prednisone
Hide Arm/Group Description:

Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.

Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.

Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.

Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.

Overall Number of Participants Analyzed 682 346
Median (95% Confidence Interval)
Unit of Measure: months
5.6
(5.49 to 5.62)
2.8
(2.79 to 2.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cabozantinib, Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments The Log-Rank Test was stratified by prior cabazitaxel, baseline pain severity, and baseline Eastern Cooperative Oncology Group Performance Status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.40 to 0.57
Estimation Comments [Not Specified]
Time Frame Up to 92 weeks
Adverse Event Reporting Description Safety was assessed based on the date of first dose and at minimum every 3 weeks up to Week 12 and every 6 weeks thereafter. The safety data includes subjects who were randomized and treated. Of 1028 patients, 682 were randomized to receive cabozantinib and 346 prednisone. The Safety population comprised of 1023 patients (681 cabozantinib, 342 prednisone).
 
Arm/Group Title Cabozantinib Prednisone
Hide Arm/Group Description

Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.

Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.

Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.

Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.

All-Cause Mortality
Cabozantinib Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cabozantinib Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   420/681 (61.67%)   181/342 (52.92%) 
Blood and lymphatic system disorders     
Anaemia  1  32/681 (4.70%)  16/342 (4.68%) 
Anaemia of malignant disease  1  1/681 (0.15%)  1/342 (0.29%) 
Disseminated intravascular coagulation  1  1/681 (0.15%)  0/342 (0.00%) 
Febrile neutropenia  1  3/681 (0.44%)  1/342 (0.29%) 
Lymphadenopathy  1  1/681 (0.15%)  0/342 (0.00%) 
Neutropenia  1  1/681 (0.15%)  1/342 (0.29%) 
Pancytopenia  1  2/681 (0.29%)  2/342 (0.58%) 
Thrombocytopenia  1  6/681 (0.88%)  4/342 (1.17%) 
Cardiac disorders     
Acute coronary syndrome  1  1/681 (0.15%)  1/342 (0.29%) 
Acute myocardial infarction  1  5/681 (0.73%)  0/342 (0.00%) 
Angina pectoris  1  2/681 (0.29%)  0/342 (0.00%) 
Arrhythmia  1  1/681 (0.15%)  0/342 (0.00%) 
Atrial fibrillation  1  5/681 (0.73%)  2/342 (0.58%) 
Atrioventricular block complete  1  1/681 (0.15%)  0/342 (0.00%) 
Cardiac arrest  1  0/681 (0.00%)  1/342 (0.29%) 
Cardiac failure  1  4/681 (0.59%)  1/342 (0.29%) 
Cardiac failure congestive  1  2/681 (0.29%)  0/342 (0.00%) 
Coronary artery stenosis  1  0/681 (0.00%)  1/342 (0.29%) 
Myocardial infarction  1  1/681 (0.15%)  1/342 (0.29%) 
Myocardial ischaemia  1  1/681 (0.15%)  0/342 (0.00%) 
Stress cardiomyopathy  1  0/681 (0.00%)  1/342 (0.29%) 
Congenital, familial and genetic disorders     
Cystic lymphangioma  1  1/681 (0.15%)  0/342 (0.00%) 
Metabolic myopathy  1  1/681 (0.15%)  0/342 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/681 (0.15%)  1/342 (0.29%) 
Endocrine disorders     
Adrenal insufficiency  1  1/681 (0.15%)  0/342 (0.00%) 
Cushing's syndrome  1  1/681 (0.15%)  0/342 (0.00%) 
Hypoaldosteronism  1  1/681 (0.15%)  0/342 (0.00%) 
Eye disorders     
Diplopia  1  1/681 (0.15%)  1/342 (0.29%) 
Visual acuity reduced  1  1/681 (0.15%)  0/342 (0.00%) 
Uveitis  1  1/681 (0.15%)  0/342 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  1/681 (0.15%)  0/342 (0.00%) 
Abdominal pain  1  8/681 (1.17%)  3/342 (0.88%) 
Abdominal pain lower  1  1/681 (0.15%)  0/342 (0.00%) 
Abdominal pain upper  1  2/681 (0.29%)  0/342 (0.00%) 
Anal fissure  1  1/681 (0.15%)  0/342 (0.00%) 
Anal fistula  1  2/681 (0.29%)  0/342 (0.00%) 
Anal inflammation  1  1/681 (0.15%)  0/342 (0.00%) 
Aphthous stomatitis  1  0/681 (0.00%)  1/342 (0.29%) 
Ascites  1  1/681 (0.15%)  1/342 (0.29%) 
Colitis ischaemic  1  1/681 (0.15%)  0/342 (0.00%) 
Constipation  1  12/681 (1.76%)  6/342 (1.75%) 
Diarrhoea  1  10/681 (1.47%)  2/342 (0.58%) 
Diverticular perforation  1  1/681 (0.15%)  0/342 (0.00%) 
Duodenal ulcer  1  1/681 (0.15%)  0/342 (0.00%) 
Dysphagia  1  1/681 (0.15%)  0/342 (0.00%) 
Enterovesical fistula  1  1/681 (0.15%)  0/342 (0.00%) 
Erosive oesophagitis  1  1/681 (0.15%)  0/342 (0.00%) 
Faecaloma  1  2/681 (0.29%)  0/342 (0.00%) 
Gastric antral vascular estasia  1  1/681 (0.15%)  0/342 (0.00%) 
Gastritis  1  0/681 (0.00%)  1/342 (0.29%) 
Gastrointestinal haemorrhage  1  3/681 (0.44%)  1/342 (0.29%) 
Gastrointestinal obstruction  1  2/681 (0.29%)  0/342 (0.00%) 
Gastrointestinal perforation  1  1/681 (0.15%)  0/342 (0.00%) 
Haematemesis  1  1/681 (0.15%)  0/342 (0.00%) 
Haemorrhoidal haemorrhage  1  2/681 (0.29%)  0/342 (0.00%) 
Inguinal hernia, obstructive  1  1/681 (0.15%)  0/342 (0.00%) 
Intestinal ischaemia  1  1/681 (0.15%)  0/342 (0.00%) 
Intestinal obstruction  1  2/681 (0.29%)  1/342 (0.29%) 
Intestinal perforation  1  1/681 (0.15%)  0/342 (0.00%) 
Intra-abdominal haemorrhage  1  0/681 (0.00%)  1/342 (0.29%) 
Large intestine perforation  1  3/681 (0.44%)  0/342 (0.00%) 
Mallory-Weiss syndrome  1  1/681 (0.15%)  0/342 (0.00%) 
Mouth ulceration  1  1/681 (0.15%)  0/342 (0.00%) 
Nausea  1  23/681 (3.38%)  6/342 (1.75%) 
Obstruction gastric  1  1/681 (0.15%)  0/342 (0.00%) 
Oesophagitis  1  1/681 (0.15%)  0/342 (0.00%) 
Pancreatitis  1  1/681 (0.15%)  0/342 (0.00%) 
Rectal haemorrhage  1  0/681 (0.00%)  1/342 (0.29%) 
Small intestinal obstrucion  1  1/681 (0.15%)  0/342 (0.00%) 
Small intestinal perforation  1  2/681 (0.29%)  0/342 (0.00%) 
Stomatitis  1  1/681 (0.15%)  0/342 (0.00%) 
Subileus  1  0/681 (0.00%)  1/342 (0.29%) 
Vomiting  1  28/681 (4.11%)  6/342 (1.75%) 
General disorders     
Asthenia  1  18/681 (2.64%)  3/342 (0.88%) 
Chest pain  1  2/681 (0.29%)  0/342 (0.00%) 
Death  1  4/681 (0.59%)  1/342 (0.29%) 
Device dislocation  1  1/681 (0.15%)  0/342 (0.00%) 
Device occlusion  1  1/681 (0.15%)  0/342 (0.00%) 
Drug withdrawal syndrome  1  1/681 (0.15%)  0/342 (0.00%) 
Euthanasia  1  3/681 (0.44%)  0/342 (0.00%) 
Fatigue  1  20/681 (2.94%)  3/342 (0.88%) 
General physical health deterioration  1  52/681 (7.64%)  22/342 (6.43%) 
Influenza like illness  1  1/681 (0.15%)  0/342 (0.00%) 
Local swelling  1  2/681 (0.29%)  1/342 (0.29%) 
Malaise  1  5/681 (0.73%)  0/342 (0.00%) 
Mucosal inflammation  1  8/681 (1.17%)  0/342 (0.00%) 
Multi-organ failure  1  2/681 (0.29%)  2/342 (0.58%) 
Non-cardiac chest pain  1  2/681 (0.29%)  1/342 (0.29%) 
Oedema peripheral  1  3/681 (0.44%)  1/342 (0.29%) 
Pain  1  10/681 (1.47%)  7/342 (2.05%) 
Performance status decreased  1  1/681 (0.15%)  0/342 (0.00%) 
Pyrexia  1  15/681 (2.20%)  6/342 (1.75%) 
Sudden death  1  1/681 (0.15%)  1/342 (0.29%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/681 (0.15%)  0/342 (0.00%) 
Bile duct stenosis  1  0/681 (0.00%)  1/342 (0.29%) 
Cholecystitis  1  2/681 (0.29%)  0/342 (0.00%) 
Hepatic failure  1  3/681 (0.44%)  0/342 (0.00%) 
Hepatitis  1  1/681 (0.15%)  0/342 (0.00%) 
Hydrocholecystis  1  1/681 (0.15%)  0/342 (0.00%) 
Hyperbilirubinaemia  1  1/681 (0.15%)  1/342 (0.29%) 
Jaundice  1  1/681 (0.15%)  0/342 (0.00%) 
Infections and infestations     
Abdominal sepsis  1  1/681 (0.15%)  0/342 (0.00%) 
Abscess  1  1/681 (0.15%)  0/342 (0.00%) 
Anal abscess  1  4/681 (0.59%)  0/342 (0.00%) 
Appendicitis  1  1/681 (0.15%)  0/342 (0.00%) 
Arthritis infective  1  1/681 (0.15%)  0/342 (0.00%) 
Aspergillus infection  1  1/681 (0.15%)  0/342 (0.00%) 
Bronchitis  1  0/681 (0.00%)  1/342 (0.29%) 
Cellulitis  1  1/681 (0.15%)  0/342 (0.00%) 
Clostridium difficile colitis  1  1/681 (0.15%)  0/342 (0.00%) 
Colonic abscess  1  3/681 (0.44%)  0/342 (0.00%) 
Cystitis  1  1/681 (0.15%)  0/342 (0.00%) 
Device related infection  1  1/681 (0.15%)  2/342 (0.58%) 
Device related sepsis  1  2/681 (0.29%)  1/342 (0.29%) 
Endocarditis  1  1/681 (0.15%)  0/342 (0.00%) 
Endocarditis staphylococcal  1  1/681 (0.15%)  0/342 (0.00%) 
Enterobacter infection  1  1/681 (0.15%)  0/342 (0.00%) 
Enterobactar sepsis  1  0/681 (0.00%)  1/342 (0.29%) 
Enterococcal sepsis  1  1/681 (0.15%)  0/342 (0.00%) 
Erysipelas  1  1/681 (0.15%)  0/342 (0.00%) 
Escherichia urinary tract infection  1  0/681 (0.00%)  1/342 (0.29%) 
Gastroenteritis  1  3/681 (0.44%)  1/342 (0.29%) 
Gastroenteritis viral  1  0/681 (0.00%)  1/342 (0.29%) 
Gastrointestinal infection  1  1/681 (0.15%)  0/342 (0.00%) 
Herpes simplex  1  1/681 (0.15%)  0/342 (0.00%) 
Herpes zoster  1  1/681 (0.15%)  0/342 (0.00%) 
Localised infection  1  1/681 (0.15%)  0/342 (0.00%) 
Lower respiratory tract infection  1  2/681 (0.29%)  1/342 (0.29%) 
Lung infection  1  5/681 (0.73%)  0/342 (0.00%) 
Neutropenic sepsis  1  1/681 (0.15%)  0/342 (0.00%) 
Oral candidiasis  1  1/681 (0.15%)  0/342 (0.00%) 
Osteomyelilitis  1  1/681 (0.15%)  0/342 (0.00%) 
Otitis externa  1  1/681 (0.15%)  0/342 (0.00%) 
Periorbital cellulitis  1  1/681 (0.15%)  0/342 (0.00%) 
Pharyngeal abscess  1  1/681 (0.15%)  0/342 (0.00%) 
Pilonidal cyst  1  1/681 (0.15%)  0/342 (0.00%) 
Pneumonia  1  17/681 (2.50%)  12/342 (3.51%) 
Pneumonia klebsiella  1  1/681 (0.15%)  0/342 (0.00%) 
Post procedural infection  1  1/681 (0.15%)  0/342 (0.00%) 
Pulmonary sepsis  1  2/681 (0.29%)  0/342 (0.00%) 
Pulpitis dental  1  0/681 (0.00%)  1/342 (0.29%) 
Pyelonephritis  1  1/681 (0.15%)  1/342 (0.29%) 
Pyelonephritis acute  1  1/681 (0.15%)  0/342 (0.00%) 
Respiratory tract infection  1  3/681 (0.44%)  0/342 (0.00%) 
Sepsis  1  11/681 (1.62%)  5/342 (1.46%) 
Septic shock  1  3/681 (0.44%)  2/342 (0.58%) 
Sinusitis  1  1/681 (0.15%)  0/342 (0.00%) 
Spinal cord infection  1  1/681 (0.15%)  5/342 (1.46%) 
Staphylococcal infection  1  0/681 (0.00%)  1/342 (0.29%) 
Staphylococcal sepsis  1  2/681 (0.29%)  1/342 (0.29%) 
Streptococcal bacteraemia  1  1/681 (0.15%)  1/342 (0.29%) 
Streptococcal infection  1  1/681 (0.15%)  0/342 (0.00%) 
Subcutaneous abscess  1  1/681 (0.15%)  0/342 (0.00%) 
Tonsillitis  1  1/681 (0.15%)  0/342 (0.00%) 
Tooth abscess  1  1/681 (0.15%)  0/342 (0.00%) 
Tracheobronchitis  1  1/681 (0.15%)  0/342 (0.00%) 
Upper respiratory tract infection  1  0/681 (0.00%)  1/342 (0.29%) 
Urinary tract infection  1  13/681 (1.91%)  6/342 (1.75%) 
Urinary tract infection enterococcal  1  0/681 (0.00%)  1/342 (0.29%) 
Urinary tract infection staphylococcal  1  1/681 (0.15%)  0/342 (0.00%) 
Urosepsis  1  7/681 (1.03%)  1/342 (0.29%) 
Viral infection  1  0/681 (0.00%)  1/342 (0.29%) 
Viral pharyngitis  1  1/681 (0.15%)  0/342 (0.00%) 
Wound infection  1  1/681 (0.15%)  0/342 (0.00%) 
Infection  1  2/681 (0.29%)  2/342 (0.58%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  0/681 (0.00%)  1/342 (0.29%) 
Chest injury  1  1/681 (0.15%)  0/342 (0.00%) 
Craniocerebral injury  1  0/681 (0.00%)  1/342 (0.29%) 
Fall  1  3/681 (0.44%)  0/342 (0.00%) 
Head injury  1  1/681 (0.15%)  0/342 (0.00%) 
Keratorhexis  1  1/681 (0.15%)  0/342 (0.00%) 
Postoperative wound complication  1  1/681 (0.15%)  0/342 (0.00%) 
Sternal fracture  1  1/681 (0.15%)  0/342 (0.00%) 
Subdural haematoma  1  2/681 (0.29%)  1/342 (0.29%) 
Toxicity to various agents  1  1/681 (0.15%)  1/342 (0.29%) 
Traumatic fracture  1  1/681 (0.15%)  0/342 (0.00%) 
Upper limb fracture  1  0/681 (0.00%)  1/342 (0.29%) 
Urostomy complication  1  1/681 (0.15%)  0/342 (0.00%) 
Wound complication  1  0/681 (0.00%)  1/342 (0.29%) 
Wound dehiscence  1  1/681 (0.15%)  0/342 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  2/681 (0.29%)  0/342 (0.00%) 
Aspartate aminotransferase increased  1  2/681 (0.29%)  0/342 (0.00%) 
Blood alkaline phosphatase increased  1  2/681 (0.29%)  0/342 (0.00%) 
Blood bilirubin increased  1  1/681 (0.15%)  0/342 (0.00%) 
Blood creatine phosphokinase increased  1  0/681 (0.00%)  1/342 (0.29%) 
Blood creatine increased  1  2/681 (0.29%)  0/342 (0.00%) 
Clostridium test positive  1  1/681 (0.15%)  0/342 (0.00%) 
Gamma-glutamyltransferase increased  1  1/681 (0.15%)  0/342 (0.00%) 
Liver function test abnormal  1  1/681 (0.15%)  2/342 (0.58%) 
Platelet count decreased  1  1/681 (0.15%)  0/342 (0.00%) 
Red blood cell count decreased  1  0/681 (0.00%)  1/342 (0.29%) 
Troponin T increased  1  0/681 (0.00%)  1/342 (0.29%) 
Metabolism and nutrition disorders     
Cachexia  1  0/681 (0.00%)  1/342 (0.29%) 
Decreased appetite  1  15/681 (2.20%)  2/342 (0.58%) 
Dehydration  1  20/681 (2.94%)  1/342 (0.29%) 
Diabetes mellitus  1  1/681 (0.15%)  2/342 (0.58%) 
Diabetes mellitus inadequate control  1  0/681 (0.00%)  1/342 (0.29%) 
Failure to thrive  1  2/681 (0.29%)  1/342 (0.29%) 
Hyperglyceaemia  1  0/681 (0.00%)  1/342 (0.29%) 
Hyperkalaemia  1  1/681 (0.15%)  1/342 (0.29%) 
Hypocalcaemia  1  3/681 (0.44%)  0/342 (0.00%) 
Hypokalaemia  1  5/681 (0.73%)  1/342 (0.29%) 
Hypomagnesaemia  1  1/681 (0.15%)  0/342 (0.00%) 
Hyponatraemia  1  7/681 (1.03%)  1/342 (0.29%) 
Hypophosphataemia  1  3/681 (0.44%)  0/342 (0.00%) 
Malnutrition  1  1/681 (0.15%)  0/342 (0.00%) 
Tumour lysis syndrome  1  1/681 (0.15%)  0/342 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  6/681 (0.88%)  4/342 (1.17%) 
Back pain  1  14/681 (2.06%)  8/342 (2.34%) 
Bone pain  1  15/681 (2.20%)  11/342 (3.22%) 
Flank pain  1  0/681 (0.00%)  1/342 (0.29%) 
Muscular weakness  1  4/681 (0.59%)  2/342 (0.58%) 
Musculoskeletal chest pain  1  2/681 (0.29%)  0/342 (0.00%) 
Musculoskeletal pain  1  3/681 (0.44%)  2/342 (0.58%) 
Myalgia  1  1/681 (0.15%)  2/342 (0.58%) 
Myositis  1  1/681 (0.15%)  0/342 (0.00%) 
Neck pain  1  3/681 (0.44%)  1/342 (0.29%) 
Osteonecrosis of jaw  1  4/681 (0.59%)  0/342 (0.00%) 
Pain in extremity  1  5/681 (0.73%)  1/342 (0.29%) 
Pathological fracture  1  4/681 (0.59%)  4/342 (1.17%) 
Rhabdomyolysis  1  2/681 (0.29%)  0/342 (0.00%) 
Spinal column stenosis  1  0/681 (0.00%)  1/342 (0.29%) 
Spinal pain  1  1/681 (0.15%)  0/342 (0.00%) 
Spondylolisthesis  1  1/681 (0.15%)  0/342 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  1/681 (0.15%)  0/342 (0.00%) 
Cancer pain  1  1/681 (0.15%)  2/342 (0.58%) 
Hormone-refractory prostate cancer  1  1/681 (0.15%)  0/342 (0.00%) 
Lymphangiosis carcinomatosa  1  1/681 (0.15%)  0/342 (0.00%) 
Malignant melanoma  1  0/681 (0.00%)  1/342 (0.29%) 
Malignant neoplasm progression  1  1/681 (0.15%)  1/342 (0.29%) 
Meningioma  1  0/681 (0.00%)  1/342 (0.29%) 
Metastases to central nervous system  1  5/681 (0.73%)  3/342 (0.88%) 
Metastases to lymph nodes  1  1/681 (0.15%)  0/342 (0.00%) 
Metastases to meninges  1  2/681 (0.29%)  0/342 (0.00%) 
Metastases to spine  1  0/681 (0.00%)  2/342 (0.58%) 
Metastatic pain  1  19/681 (2.79%)  12/342 (3.51%) 
Myelodysplastic syndrome  1  0/681 (0.00%)  1/342 (0.29%) 
Neoplasm progression  1  1/681 (0.15%)  0/342 (0.00%) 
Nodular melanoma  1  1/681 (0.15%)  0/342 (0.00%) 
Pancreatic carcinoma  1  1/681 (0.15%)  0/342 (0.00%) 
Prostate cancer  1  52/681 (7.64%)  27/342 (7.89%) 
Prostate cancer metastatic  1  0/681 (0.00%)  1/342 (0.29%) 
Second primary malignancy  1  1/681 (0.15%)  0/342 (0.00%) 
Tumour haemorrhage  1  1/681 (0.15%)  0/342 (0.00%) 
Tumour pain  1  1/681 (0.15%)  0/342 (0.00%) 
Nervous system disorders     
Cauda equina syndrome  1  1/681 (0.15%)  1/342 (0.29%) 
Cerebellar infarction  1  1/681 (0.15%)  0/342 (0.00%) 
Cerebral haematoma  1  2/681 (0.29%)  0/342 (0.00%) 
Cerebral haemorrhage  1  3/681 (0.44%)  0/342 (0.00%) 
Cerebral infarction  1  1/681 (0.15%)  0/342 (0.00%) 
Cerebral ischaemia  1  2/681 (0.29%)  1/342 (0.29%) 
Cerebrovascular accident  1  4/681 (0.59%)  3/342 (0.88%) 
Cognitive disorder  1  1/681 (0.15%)  0/342 (0.00%) 
Convulsion  1  1/681 (0.15%)  1/342 (0.29%) 
Dizziness  1  2/681 (0.29%)  0/342 (0.00%) 
Dyskinesia  1  1/681 (0.15%)  0/342 (0.00%) 
Facial paresis  1  1/681 (0.15%)  0/342 (0.00%) 
Haemorrhage intracranial  1  1/681 (0.15%)  0/342 (0.00%) 
Headache  1  2/681 (0.29%)  3/342 (0.88%) 
Hemiparesis  1  0/681 (0.00%)  1/342 (0.29%) 
Hypoaesthesia  1  1/681 (0.15%)  4/342 (1.17%) 
Ischaemic stroke  1  1/681 (0.15%)  1/342 (0.29%) 
Lethargy  1  2/681 (0.29%)  0/342 (0.00%) 
Leukoencephalopathy  1  1/681 (0.15%)  0/342 (0.00%) 
Loss of consciousness  1  3/681 (0.44%)  1/342 (0.29%) 
Memory impairment  1  0/681 (0.00%)  1/342 (0.29%) 
Metabolic encephalopathy  1  1/681 (0.15%)  0/342 (0.00%) 
Nerve root compression  1  1/681 (0.15%)  1/342 (0.29%) 
Paraesthesia  1  1/681 (0.15%)  0/342 (0.00%) 
Paraparesis  1  0/681 (0.00%)  2/342 (0.58%) 
Paralpegia  1  0/681 (0.00%)  2/342 (0.58%) 
Parkinson's disease  1  1/681 (0.15%)  0/342 (0.00%) 
Peripheral motor neuropathy  1  1/681 (0.15%)  0/342 (0.00%) 
Presyncope  1  1/681 (0.15%)  1/342 (0.29%) 
Quadriparesis  1  1/681 (0.15%)  0/342 (0.00%) 
Sciatica  1  1/681 (0.15%)  0/342 (0.00%) 
Sensorimotor disorder  1  0/681 (0.00%)  1/342 (0.29%) 
Sensory loss  1  0/681 (0.00%)  1/342 (0.29%) 
Somnolence  1  1/681 (0.15%)  0/342 (0.00%) 
Spinal cord compression  1  14/681 (2.06%)  8/342 (2.34%) 
Spinal cord paralysis  1  0/681 (0.00%)  1/342 (0.29%) 
Stupor  1  1/681 (0.15%)  0/342 (0.00%) 
Syncope  1  5/681 (0.73%)  2/342 (0.58%) 
Radiculitis  1  0/681 (0.00%)  1/342 (0.29%) 
Psychiatric disorders     
Agitation  1  1/681 (0.15%)  0/342 (0.00%) 
Anxiety  1  1/681 (0.15%)  1/342 (0.29%) 
Confusional state  1  7/681 (1.03%)  0/342 (0.00%) 
Delirium  1  2/681 (0.29%)  1/342 (0.29%) 
Depression  1  0/681 (0.00%)  1/342 (0.29%) 
Renal and urinary disorders     
Bladder dysfunction  1  0/681 (0.00%)  1/342 (0.29%) 
Bladder outlet obstruction  1  0/681 (0.00%)  1/342 (0.29%) 
Calculus bladder  1  1/681 (0.15%)  0/342 (0.00%) 
Dysuria  1  0/681 (0.00%)  1/342 (0.29%) 
Haematuria  1  5/681 (0.73%)  3/342 (0.88%) 
Hydronephrosis  1  5/681 (0.73%)  4/342 (1.17%) 
Hydroureter  1  1/681 (0.15%)  0/342 (0.00%) 
Nephrolithiasis  1  1/681 (0.15%)  0/342 (0.00%) 
Prerenal failure  1  1/681 (0.15%)  0/342 (0.00%) 
Renal failure  1  2/681 (0.29%)  3/342 (0.88%) 
Renal failure acute  1  12/681 (1.76%)  4/342 (1.17%) 
Renal impairment  1  1/681 (0.15%)  1/342 (0.29%) 
Ureteric stenosis  1  1/681 (0.15%)  0/342 (0.00%) 
Urethral obstruction  1  1/681 (0.15%)  0/342 (0.00%) 
Urinary bladder haemorrhage  1  1/681 (0.15%)  0/342 (0.00%) 
Urinary retention  1  7/681 (1.03%)  1/342 (0.29%) 
Urinary tract disorder  1  1/681 (0.15%)  0/342 (0.00%) 
Urinary tract obstruction  1  4/681 (0.59%)  1/342 (0.29%) 
Reproductive system and breast disorders     
Pelvic pain  1  1/681 (0.15%)  0/342 (0.00%) 
Penile swelling  1  1/681 (0.15%)  0/342 (0.00%) 
Perineal pain  1  0/681 (0.00%)  1/342 (0.29%) 
Scrotal swelling  1  1/681 (0.15%)  0/342 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  2/681 (0.29%)  0/342 (0.00%) 
Chronic obstructive pulmonary disease  1  0/681 (0.00%)  1/342 (0.29%) 
Dysphonia  1  2/681 (0.29%)  0/342 (0.00%) 
Dyspnoea  1  10/681 (1.47%)  3/342 (0.88%) 
Emphysema  1  1/681 (0.15%)  0/342 (0.00%) 
Epistaxis  1  5/681 (0.73%)  2/342 (0.58%) 
Haemoptysis  1  1/681 (0.15%)  0/342 (0.00%) 
Lung disorder  1  1/681 (0.15%)  0/342 (0.00%) 
Pleural effusion  1  9/681 (1.32%)  3/342 (0.88%) 
Pneumonia aspiration  1  1/681 (0.15%)  0/342 (0.00%) 
Pneumothorax  1  4/681 (0.59%)  0/342 (0.00%) 
Pulmonary embolism  1  42/681 (6.17%)  3/342 (0.88%) 
Pulmonary oedema  1  1/681 (0.15%)  0/342 (0.00%) 
Respiratory failure  1  3/681 (0.44%)  1/342 (0.29%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/681 (0.15%)  0/342 (0.00%) 
Decubitus ulcer  1  1/681 (0.15%)  1/342 (0.29%) 
Palmar-plantar erythrodysaesthesia syndrome  1  3/681 (0.44%)  0/342 (0.00%) 
Rash  1  1/681 (0.15%)  0/342 (0.00%) 
Rash macular  1  1/681 (0.15%)  0/342 (0.00%) 
Skin ulcer  1  2/681 (0.29%)  0/342 (0.00%) 
Stasis dermatitis  1  1/681 (0.15%)  0/342 (0.00%) 
Vascular disorders     
Aortic aneurysm rupture  1  1/681 (0.15%)  0/342 (0.00%) 
Arterial occlusive disease  1  1/681 (0.15%)  0/342 (0.00%) 
Circulatory collapse  1  0/681 (0.00%)  1/342 (0.29%) 
Deep vein thrombosis  1  11/681 (1.62%)  3/342 (0.88%) 
Hypertension  1  7/681 (1.03%)  2/342 (0.58%) 
Hypertensive crisis  1  1/681 (0.15%)  1/342 (0.29%) 
Hypotension  1  4/681 (0.59%)  2/342 (0.58%) 
Malignant hypertension  1  1/681 (0.15%)  0/342 (0.00%) 
Orthostatic hypotension  1  3/681 (0.44%)  0/342 (0.00%) 
Peripheral arterial occlusive disease  1  1/681 (0.15%)  1/342 (0.29%) 
Peripheral ischaemia  1  0/681 (0.00%)  1/342 (0.29%) 
Shock haemorrhagic  1  0/681 (0.00%)  1/342 (0.29%) 
Venous haemorrhage  1  1/681 (0.15%)  0/342 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cabozantinib Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   675/681 (99.12%)   332/342 (97.08%) 
Blood and lymphatic system disorders     
Anaemia  1  203/681 (29.81%)  111/342 (32.46%) 
Thrombocytopenia  1  42/681 (6.17%)  20/342 (5.85%) 
Endocrine disorders     
Hypothyroidism  1  94/681 (13.80%)  1/342 (0.29%) 
Gastrointestinal disorders     
Abdominal pain  1  76/681 (11.16%)  16/342 (4.68%) 
Abdominal pain upper  1  43/681 (6.31%)  16/342 (4.68%) 
Constipation  1  227/681 (33.33%)  100/342 (29.24%) 
Diarrhoea  1  349/681 (51.25%)  68/342 (19.88%) 
Dry mouth  1  65/681 (9.54%)  11/342 (3.22%) 
Dyspepsia  1  58/681 (8.52%)  6/342 (1.75%) 
Dysphagia  1  41/681 (6.02%)  0/342 (0.00%) 
Gastrooesophageal reflux disease  1  37/681 (5.43%)  7/342 (2.05%) 
Nausea  1  390/681 (57.27%)  102/342 (29.82%) 
Stomatits  1  127/681 (18.65%)  8/342 (2.34%) 
Vomiting  1  271/681 (39.79%)  67/342 (19.59%) 
General disorders     
Asthenia  1  228/681 (33.48%)  63/342 (18.42%) 
Fatigue  1  338/681 (49.63%)  119/342 (34.80%) 
General physical health deterioration  1  47/681 (6.90%)  13/342 (3.80%) 
Muscosal inflammation  1  134/681 (19.68%)  9/342 (2.63%) 
Oedema peripheral  1  101/681 (14.83%)  43/342 (12.57%) 
Pain  1  56/681 (8.22%)  33/342 (9.65%) 
Pyrexia  1  67/681 (9.84%)  36/342 (10.53%) 
Infections and infestations     
Urinary tract infection  1  71/681 (10.43%)  29/342 (8.48%) 
Investigations     
Alanine aminotransferase increased  1  56/681 (8.22%)  10/342 (2.92%) 
Aspartate aminotransferase increased  1  70/681 (10.28%)  14/342 (4.09%) 
Weight decreased  1  237/681 (34.80%)  41/342 (11.99%) 
Metabolism and nutrition disorders     
Decreased appetite  1  407/681 (59.77%)  99/342 (28.95%) 
Dehydration  1  38/681 (5.58%)  15/342 (4.39%) 
Hypocalcaemia  1  50/681 (7.34%)  20/342 (5.85%) 
Hypokalaemia  1  69/681 (10.13%)  9/342 (2.63%) 
Hypomagnesaemia  1  36/681 (5.29%)  3/342 (0.88%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  91/681 (13.36%)  50/342 (14.62%) 
Back pain  1  115/681 (16.89%)  64/342 (18.71%) 
Bone pain  1  109/681 (16.01%)  63/342 (18.42%) 
Muscle spasms  1  48/681 (7.05%)  20/342 (5.85%) 
Muscular weakness  1  48/681 (7.05%)  22/342 (6.43%) 
Musculoskeletal pain  1  43/681 (6.31%)  37/342 (10.82%) 
Pain in extremity  1  98/681 (14.39%)  36/342 (10.53%) 
Nervous system disorders     
Dizziness  1  48/681 (7.05%)  19/342 (5.56%) 
Dysgeusia  1  175/681 (25.70%)  16/342 (4.68%) 
Headache  1  87/681 (12.78%)  14/342 (4.09%) 
Psychiatric disorders     
Depression  1  42/681 (6.17%)  11/342 (3.22%) 
Insomnia  1  53/681 (7.78%)  28/342 (8.19%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  52/681 (7.64%)  15/342 (4.39%) 
Dysphonia  1  180/681 (26.43%)  21/342 (6.14%) 
Dyspnoea  1  135/681 (19.82%)  46/342 (13.45%) 
Epistaxis  1  37/681 (5.43%)  9/342 (2.63%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  53/681 (7.78%)  8/342 (2.34%) 
Palmar-plantar erythrodysaesthesia syndrome  1  200/681 (29.37%)  5/342 (1.46%) 
Vascular disorders     
Hypertension  1  191/681 (28.05%)  38/342 (11.11%) 
Hypotension  1  36/681 (5.29%)  13/342 (3.80%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
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.
Our agreements with investigators vary; constant is our right to review results communications prior to public release, and embargo communications for a period of ≤60 days from submittal for review. We do not prohibit investigators from publishing, but we may require previously undisclosed confidential information, other than study results, to be removed from publications, and single-center publications are postponed until after publication of the trial's primary multicenter publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Exelixis Medical Information
Organization: Exelixis, Inc.
Phone: 855-292-3935
EMail: druginfo@exelixis.com
Layout table for additonal information
Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01605227    
Other Study ID Numbers: XL184-307
2012-001834-33 ( EudraCT Number )
First Submitted: May 22, 2012
First Posted: May 24, 2012
Results First Submitted: May 23, 2017
Results First Posted: March 14, 2018
Last Update Posted: March 14, 2018